impetus - health sciences authority...impetus – the eighth annual report of the health sciences...

Impetus

H e a l t h S c i e n c e s A u t h o r i t yA n n u a l R e p o r t

2 0 0 8 - 0 9

Vision • Mission • Values 02• Our Accolades 03• Chairman’s Foreword 06• CEO’s Preface 10• HSA Board 14• HSA Executive Committee 17• Corporate Goverance Statement 18• Organisation Chart 20• Principal Officers 21

• Corporate Headquarters 26

• Health Products Regulation Group 32

• Blood Services Group 44

• Applied Sciences Group 50

• Research Papers and Projects 56

• Financial Highlights 61

Contents

Impetus

Impetus

Over the past year, an unprecedented global financial economic crisis and the

developing Influenza A (H1N1-2009) pandemic have combined with accelerating

advances in the scientific areas of relevance to HSA to rescope the challenges of

the dynamic environment in which our organisation operates.

HSA has responded to these developments with equanimity, reviewing our priorities,

strategies and business continuity plans to ensure relevant and timely responses,

while never losing sight of our vision of protecting and advancing national health

and safety. We continue to be fired by the impetus of shaping an HSA that will not

only meet the challenges of the present but take us into the future, living out our

Core Values to fulfill our fundamental mission of safeguarding public health.

This impetus is driven by the unique combination of skills and strengths from the

dedicated team that makes up HSA. Our Corporate Headquarters strategically drives

all policies and programmes in sync with the organisation’s overall direction.

Our Health Products Regulation Group vigilantly ensures that its regulatory decisions

are not only managing key issues in the ever-evolving biomedical, economic and

social landscape, but are also addressing them in innovative ways. Our Blood

Services Group steadfastly keeps in focus its mission to provide our nation with a

safe and sustainable blood supply, while promoting cutting edge research in cell

processing. Our Applied Sciences Group is consistently committed to authoritative

actions that ensure sound and current decisions in the forensic and analytical

sciences, and growing the new area of chemical metrology.

We are confident that we can and will continue to advance and meet the challenges

of the future with momentum, focus, determination and ingenuity -

a synergised scientific authority inspiring trust, serving our nation.

H S A A n n u a l R e p o r t 2 0 0 8 - 0 90 1

Our VisionTo be the leading innovative authority protectingand advancing national health and safety

Our Mission• To wisely regulate health products• To serve the administration of justice• To secure the nation’s blood supply• To safeguard public health

Our Core Values• Service to the Nation

We are part of the Singapore Public Service,committed to integrity, excellence and efficiency.

• Passion for ExcellenceWe aim to be the best in all that we do.

• Develop Our CommunityWe value our people and build trusted teams.

• Inspire TrustWe act with credibility, professionalism and integrity,to instill public trust and confidence.

• Live InnovationWe seek constantly to improve and transform.

A Statutory Board of the Ministry of HealthThe Singapore Public Service: Integrity, Service, Excellence


Our AccoladesOur Accolades

ORGANISATIONAL EXCELLENCESingapore Quality Class

since 2009

People Developer Standard Certificationsince 2002

Singapore Innovation Classfirst public healthcare agency to be endorsed

2003

Singapore H.E.A.L.T.H. Gold Awardsince 2005

Public Service Award for Organisational Excellence2006

Meritorious Defence Partner Awardsince 2005

Community Chest Awardssince 2003

Singapore Family Friendly Employer Award2004

ISO 9001:2000Information Management Department, Corporate HQ

2007


PROFESSIONAL EXCELLENCE

HEALTH PRODUCTS REGULATION GROUPISO 9001:2000

Tobacco Regulation UnitMarch 2008

BLOOD SERVICES GROUPAmerican Society for Histocompatibility and Immunogenetics (ASHI)

August 2008

AABB Accreditationfirst national blood service in Asia to be accredited

May 2006

Certified On-the-Job Training CentreDecember 2005

Regional Quality Management Project Training Centre of theWestern Pacific for Transfusion Medicine

since 2002

World Health Organisation Collaborating Centre for Transfusion Medicinesince 1992


H S A A n n u a l R e p o r t 2 0 0 8 - 0 9X X

APPLIED SCIENCES GROUP

Forensic Medicine DivisionNational Association of Medical Examiners (NAME)

first agency outside North America to be accreditedSeptember 2005

Commendation for Significant Contribution in Helping Singapore Overcome SARSMarch - May 2003

Accreditation of Laboratory for Pathology Trainingby The Royal College of Pathologists of Australasia

since 1999

Forensic Science Division & Illicit Drugs and Toxicology DivisionExcellence for Singapore Award

1999

American Society of Crime Laboratory Directors/Laboratory Accreditation Board (ASCLD/LAB)

since June 1996

Pharmaceutical Division & Food Safety DivisionPublic Service Award for Organisational Excellence

July 2003

Singapore Quality Classsince August 2002

ISO/IEC 17025 Accreditation under Singapore Accreditation Council– Singapore Laboratory Accreditation Scheme (SAC-SINGLAS)

since 1997

Pharmaceutical DivisionWorld Health Organisation Collaborating Centre

for Tobacco Testing and Researchsince June 2009

World Health Organisation Prequalified Quality Control Laboratorysince June 2009

EC-ASEAN Leading Country for Colourants and Tretinoin Analysis in Cosmetic Productssince 2004

World Health Organisation Collaborating Centre for Drug Quality Assurancesince February 1993

Food Safety DivisionEC-ASEAN Reference Laboratory for Mycotoxins Analysis

since June 2004

World Health Organisation Collaborating Centre for Food Contamination Monitoringsince July 1992

H S A A n n u a l R e p o r t 2 0 0 8 - 0 905

Chairman’sForeword



Impetus – the eighth Annual Report of the Health Sciences Authority – fittingly encapsulates the essenceof the agency’s progress and priorities over the past year.

Driven by a spirit of innovation, we rose to meet the challenges and demands of our ever-evolvingenvironment. Whether through adjustments of work processes, or by effecting major change in testingmethods from our scientific research, we were constantly on the lookout for newer and better ways to runour business, advance our science-based agenda, and exceed the expectations of our stakeholders.

HSA continually strives to safeguard public health and has implemented plans and strategies in supportof this. We do this with a strong mission-oriented mindset, conscious of the critical role we play instrengthening Singapore’s reputation as a leading medical hub and centre of biomedical excellence.

We directed efforts towards strengthening ties and partnerships with parties and agencies in the public,private and people sectors, both locally and overseas. These collaborative alliances continue to provide uswith a greater capacity to develop more creative and practical solutions to deal with global and localmatters in the health sciences.

Through fresh approaches in our business operations and new communication channels, we redoubled ourefforts to engage our customers and improve the experience of individuals and organisations interactingwith HSA staff.

There was a palpable sense of excitement as we grew in new ways. We had the privilege of sharing ourexpertise, experiences and successes with various audiences around the world and who were keen to learnabout our experiences. Such opportunities allow us to influence national and global public health andsafety in a positive and sustainable manner.


Our distinctive blend of professional expertise and know-how presents unique possibilities to exploreinnovation in our regulatory and laboratory arenas. We continued to harness synergy within and acrossour organisation which helped us deliver on our key accountabilities more competently and efficiently.Our Applied Sciences Group expanded the accredited screening list for western drug adulterants in herbalmedicines, as well as applied conventional and novel forensic techniques to enhance our Health ProductsRegulation Group’s enforcement capabilities and advance our fight against illegal and counterfeit drugs.Drawing on this in-house expertise across a broad spectrum of scientific fields will not just strengthen theunified identity of HSA, but will empower us to forge fresh momentum to continually transform ourselvesand actively shape our future.

As a science-based and science-led organisation, our decisions and actions are always guided by the higheststandards of professional integrity and scientific rigour. This is strongly linked to our aim to inspire trustand confidence in meeting the needs of our stakeholders and finding solutions for critical issues that wedeal with, regardless of how complex these may be.

We have much going for us, in spite of being a relatively young organisation. We have many good reasonsto be optimistic about our future, and these give us the added impetus to grow and advance. Bolsteredby the professionalism and passion of the HSA team, this outlook is founded on the underlying strengthsof the firm scientific foundations and legacy on which our organisation is built, the tremendous potentialof synergistic collaborations within the agency, the power of partnerships with our key counterparts locallyand globally, and the promise of new breakthroughs in our research and scientific and organisationalcollaborations.

I would like to commend and thank the leadership and staff of HSA for another year of sterling work anddedication in enabling our agency to move decisively forward in serving the nation and the world.

Professor Edison LiuChairman

H S A A n n u a l R e p o r t 2 0 0 8 - 0 9X X

CEO’s Preface



HSA continued to make good progress over the past year in a dynamic operatingenvironment. Through the strong commitment of the HSA team, we became a SingaporeQuality Class organisation this year and were also re-certified for the People Developerand Singapore Innovation Class standards. This affirmed that our key organisationalsystems, processes and initiatives are robust and responsive for our journey ahead.We continued to strongly emphasize our Core Values and living these out to growthe responsible, innovative culture rightfully associated with a national scientific andregulatory authority.

We completed a holistic review of our human capital framework that simplified andstreamlined our schemes of service. From this, we rolled out a new performanceappraisal framework to enable clearer target setting, enhanced transparency inperformance assessment, and more fruitful interactions between supervisors andstaff. The establishment of a HSA Professional Board, the introduction of a clearprofessional staff track, and the ongoing review of our talent development frameworkwill serve to empower and grow all members of the HSA family as they contributeand achieve their potential. We also refreshed the connections between our businessdecisions and various social and environmental concerns through a new corporatesocial responsibility framework.

Our Corporate Headquarters was restructured to ensure better coordination in orderto provide clear directions and support to better harness the synergies of our professionalgroups. Our strategic planning process and service quality initiatives continue to beenhanced, and we are looking into strengthening our risk management and processmanagement systems.

At our Health Products Regulation Group, we continued with the rollout of the HealthProducts Act, particularly the requirements in the medical devices and cosmeticsregulatory frameworks. This was balanced by initiatives to minimise unnecessaryregulatory costs and administrative process. Listening to our stakeholders, respondingto their concerns promptly, and refining our regulatory policies and frameworksaccordingly were accorded high priority to strengthen our pro-enterprise orientation.We made several improvements to our work processes by introducing more efficientways of working, while promoting integrity, responsibility and transparency in ourpublic health protection mission.

Our Blood Services Group spared no effort in making sure that a safeand stable supply of whole blood and blood products is available toevery patient in need. We achieved accreditation to the moststringent current international safety and quality standards for tissuetyping and transplant support activities. We pressed on in developingprocedures and practices to promote blood conservation and ensurewe remain a premier blood bank and critical national resource. Asan active member of the international community, we also mademany useful contributions in blood banking and transfusion medicinethrough participation in global forums and providing consultancyadvice to other standard-setting bodies. We also continued toadvance on the pioneering research and service front. With thesuccess of our pilot Cell Processing Laboratory, we are now expandingour facilities to undertake more collaborative projects with clinicalcolleagues, applying cells such as natural killer cells and haematopoieticstem cells for therapeutic use.

Stability, reliability, consistency and quality were what the laboratoriesat our Applied Sciences Group continued to offer to all our clients. Thiswas made possible with a proven track record founded on sound scientificexpertise and strong synergy amongst the various scientific disciplinesacross our laboratories. With our strong orientation towards creatingmore value-add for our customers, we developed a host of innovativeproducts and testing methods in-house that will offer our customersfaster turnaround times and renewed assurance in the quality of ourservices. We also look forward to the opening of our new ChemicalMetrology Laboratory, currently being purpose-built in a cleanroomenvironment, in August 2009. This will add another new capability anddimension to our growing pool of expertise in the applied sciences.

A vibrant and productive research environment in our areas ofscientific expertise will be a vital catalyst for the expansion of ourcurrent work scope and open up new areas of innovation andexcellence. We are excited by new developments already shapingup in promising fields such as pharmacogenomics and cellular therapy,and seeing ideas and hypotheses being transformed into powerful,practical solutions to improve the quality of healthcare. This willenable an even stronger and more concrete expression of our missionimperatives.

Our ongoing ability to form new alliances will significantly addbreadth and scale to our capabilities. These partnerships, particularlythrough worksharing collaborations with our internationalcounterparts, give us the opportunity to share our unique perspectivesand develop thought leadership as a valued global partner in healthsciences. Having hosted the 3rd Summit of Heads of MedicinesRegulatory Agencies in December last year, we now look forward toco-hosting the 14th International Conference of Drug RegulatoryAuthorities with the World Health Organisation, in September 2010.

Much of what you will read in the following pages reflect thesuccessful partnerships we have with our parent Ministry, our Boardand our partners in Government, industry and overseas counterpartagencies. We thank them for their collaboration and counsel whichnot only have energised us but enabled us to function more effectively.

The future is uncertain but also exciting and full of opportunity. Wechoose to set our sights on the limitless possibilities, building ourstakeholders’ trust and confidence in what HSA has already accomplishedand the potential and promise it holds. This will galvanise our thinkingand actions throughout our organisation, and be the impetus for us topress on towards achieving our goals and mission in a transformationalmanner.

Dr John LimChief Executive Officer


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Chairman01. Professor Edison Liu

Executive DirectorGenome Institute of Singapore

Board Members02. Professor Alastair Campbell

Director, Centre for Biomedical EthicsYong Loo Lin School of MedicineNational University of Singapore

03. Dr Chong Yoke SinChief Executive OfficerIntegrated Health Information Systems Pte Ltd

04. Dr Lee Chien EarnSenior DirectorHealthcare Performance GroupMinistry of Heath

HSA Boardas at August 2009


07. 08. 09.

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05. Dr Jennifer LeeSenior ConsultantPrimary & Community Care DivisionMinistry of Health

06. Mdm Liew Wei LiPrincipalXinmin Secondary School

07. Dr John LimChief Executive OfficerHealth Sciences Authority

08. Professor Walter TanMedical DirectorRaffles Hospital

09. Ms Serene WeeChief ExecutiveSingapore Academy of Law


HSA Board Committeesas at August 2009

Audit Committee• Ms Serene Wee Chairman

• Dr Lee Chien Earn Member

• Professor Walter Tan Member

Staff Establishment Committee• Dr Jennifer Lee Chairman

• Professor Alastair Campbell Member

• Mdm Liew Wei Li Member

Finance Committee• Dr Chong Yoke Sin Chairman

• Dr Jennifer Lee Member

• Dr Lee Chien Earn Member

Board ChangesWe would like to express our deepest appreciation to Professor Low Teck Seng

who stepped down from the HSA Board on 31 January 2009.

Since 2002, Professor Low had served on the HSA Board and its committees,notably as Chairman of the Audit Committee. He has provided much valuable

guidance and useful insight in advancing HSA’s work.

We would like to thank him for his significant contributions, leadership andgenerous support of HSA’s programmes and activities over the years.



HSA Executive Committee (EXCO)(as at August 2009)

L to R:

Dr Diana Teo• Group Director, Blood Services Group• Chairman, Professional Board

Ms Doreen Loh• Division Director, Human Capital & Legal Division,

Corporate Headquarters

Dr Lam Kian Ming• Division Director, Strategic Planning, Operations

& Communications Division, Corporate Headquarters

Ms Maureen Goh• Quality Service Manager• Director, Quality Management Department,


Dr John Lim• Chief Executive Officer• Group Director (covering),

Health Products Regulation Group

Dr Paul Chui• Group Director, Applied Sciences Group• Division Director, Forensic Medicine Division,

Applied Sciences Group

Dr Christina Lim• Deputy Group Director,



Corporate Governance Statement

The HSA Board and Senior Management Team are committed to maintain a high standard of corporategovernance and advocate the recommendations set out by the Code of Corporate Governance. The Boardbelieves that good governance is essential in enhancing corporate performance and accountability, ensuringtransparency and protecting stakeholders’ interests at all times. Our stakeholders include the Ministry ofHealth, Ministry of Finance, other government agencies, the healthcare industry, our clients, our suppliersand the public at large.

This statement outlines the main corporate governance practices of the organisation that are in place.

The BoardThe Board comprises the Chairman and its members, who are appointed by the Minister for Health for a3-year term. It aims to meet every two months to set strategic directions and formulate policies, assumingthe role of monitoring and reviewing of policies leading to HSA’s improved management and performance.

Board Members’ RemunerationHSA follows the Government’s Directorship and Consultancy Appointments Council (DCAC) guidelines indetermining the remuneration of the Board Members.

Notice and Declaration of Directorships and Interest in Shares and DebenturesBoard Members are required to declare their directorships in various organisations and their interests inshares and debentures in various corporations. Board Members deemed to be interested in any suchtransactions made during the meetings are reminded and required to declare their interest; they are torefrain from any deliberation made when such an interest has been declared.

Accountability and AuditHSA’s Senior Management Team is accountable to the Board. In return, the Board is accountable to theMinister for Health. To allow the Board to discharge their duties adequately, Senior Management and staffare required to provide periodic updates and answer any queries that the Board may have on the operationsand planning of the organisation.


For Accountability purposes, the Board has established the following sub-committees:

(a) The Audit CommitteeThis Committee assists the Board to review and assess the adequacy of internal accounting controlsand financial reporting controls. It meets at least twice a year with the Management and auditors todetermine the scope of the external and internal audit and to review the findings of its appointedauditors.

(b) The Staff Establishment CommitteeThe Staff Establishment Committee assists the Board in reviewing the adequacy of manpower numbersand budgets to meet operational needs and major Human Resource Policies regarding compensation.It oversees some staff matters such as the appointment of senior management positions.

(c) The Finance CommitteeThis Committee assists the Board in ensuring that financial resources are managed and utilised prudentlyand in the most effective and efficient manner, contributing towards the organisation’s overall mission.

Communication with StakeholdersThe professional groups conduct regular consultations with the industry and their clients, seeking to keepthem informed of new directions and regulations, and to listen to their concerns. HSA publishes an annualreport to meet statutory requirements and to provide information to our stakeholders.

In addition, regular updates on matters of interest to our stakeholders are posted on our Internet website.Our Quality Service Manager promptly handles all feedback and queries received from interested parties.

Code of Business ConductThe Board, officers and employees are required to observe and maintain high standards of integrity, andare in compliance with the law and government regulations, and organisation policies.

Risk ManagementThe Management is continually reviewing and improving the business and operational activities to identifyareas of significant business risks as well as appropriate measures to control and mitigate these risks. TheManagement also reviews all significant control policies and procedures and highlights all significant mattersto the Board and the Audit Committee.


Organisation Chartas at August 2009

Chief Executive Officer

HSA Board

CorporateHeadquarters

AppliedSciencesGroup

BloodServicesGroup

HealthProducts

RegulationGroup


STRATEGIC PLANNING, OPERATIONS &COMMUNICATIONS DIVISIONDivision DirectorDr Lam Kian Ming

Corporate CommunicationsDirectorMs Jeannie Thng

HUMAN CAPITAL & LEGAL DIVISIONDivision DirectorMs Doreen Loh

Manpower Planning & StaffingDirectorMrs Sarojini Padmanathan

LegalHeadMs Linda Chen

FINANCE DEPARTMENTDirectorMs Grace Chan

OPERATIONS MANAGEMENT DEPARTMENTChief Information Officer & DirectorLam Kee Sin

Facilities ManagementDirectorChua Hong Tong

Information ManagementDirectorChan Chin Wai

QUALITY MANAGEMENT DEPARTMENTDirector/Quality Service ManagerMs Maureen Goh

PROFESSIONAL QUALITY/WORKPLACE SAFETYAND HEALTH DEPARTMENTDirectorProfessor Bosco Chen Bloodworth

CORPORATE HEADQUARTERS

L to R:• Chua Hong Tong • Ms Grace Chan • Lam Kee Sin• Chan Chin Wai • Professor Bosco Chen Bloodworth• Ms Jeannie Thng • Mrs Sarojini Padmanathan

Absent:• Ms Linda Chen

Principal Officersas at August 2009


HEALTH PRODUCTS REGULATION GROUP

Dr John Lim

Dr Christina Lim

GROUP DIRECTOR’S OFFICEDirector, AdministrationMdm Suwarin Chaturapit

Director, Regulatory Operations & PlanningDr Daniel Tan

Director, ResearchMs Chan Cheng Leng

Deputy Director, Regulatory Policy & PlanningMs Lee Hui Keng

Deputy Director, Legislative PolicyKelvin Tan

THERAPEUTIC PRODUCTS DIVISIONPharmaceuticals & Biologics BranchDeputy DirectorDr Thomas Soo

Deputy Director, Clinical Regulatory UnitDr Lou Huei-Xin

Deputy Director, Quality Regulatory UnitDr Sannie Chong

Clinical Trials BranchDeputy DirectorFoo Yang Tong

Medical Device BranchDirectorMs Joanna Koh

Deputy Director, Licensing & Surveillance Unit(vacant)

Deputy Director, Evaluation UnitSeet Wing Gang

COMPLEMENTARY HEALTH PRODUCTS DIVISIONDivision DirectorYee Shen Kuan

Deputy Division Director &Deputy Director, Cosmetics Control UnitMrs Marie Tham

Complementary Medicines BranchDirector &Deputy Director (covering),Chinese Propriety Medicines UnitMs Chu Swee Seng

Deputy Director, Health Supplements UnitVictor Wong

L to RFront:• Dr Sannie Chong • Mdm Suwarin Chaturapit • Dr Daniel Tan• Mrs Marie Tham

Back:• Ms Joanna Koh • Foo Yang Tong • Dr Thomas Soo • Ms Lee Hui Keng• Ms Chan Cheng Leng

Absent:• Kelvin Tan • Dr Lou Huei-Xin • Seet Wing Gang


MANUFACTURING & QUALITY AUDIT DIVISIONDivision Director &Deputy Director (covering), Pharmaceutical Audit UnitSia Chong Hock

GMP Audit BranchConsultant, Biologics & Cell & Tissue Therapy Audit UnitMs Jessica Teo

Deputy Director, Natural Health Products Audit UnitNg Liong Thiam

Deputy Director, Overseas Audit UnitBoon Meow Hoe

Deputy Director, Good Distribution Practice UnitMs Hui Foong Mei

Deputy Director, Certification UnitDr Lai Weng Fai

PHARMACOVIGILANCE &COMPLIANCE DIVISIONDivision Director &Director (covering), Pharmacovigilance BranchMs Chan Cheng Leng

Deputy Director, Medical Advertisements UnitMs Lee Puey Ngee

ENFORCEMENT DIVISIONDivision DirectorYee Shen Kuan

Enforcement BranchDeputy Director &Deputy Director, Prosecution UnitKelvin Tan

Deputy Director, Enforcement Intelligence UnitMs Ling Boon Lee

Deputy Director, Surveillance UnitR. Sivalingam

Deputy Director, Enforcement Operations UnitMs Ruth Lee

Deputy Director, Tobacco Regulation UnitNorman Chong

L to RFront:• Ms Hui Foong Mei • Sia Chong Hock • Ng Liong Thiam• Ms Ling Boon Lee • Ms Jessica Teo

Back:• Norman Chong • Victor Wong • R. Sivalingam • Boon Meow Hoe • Ms Ruth Lee

Absent:• Yee Shen Kuan • Ms Chu Swee Seng • Dr Lai Weng Fai• Ms Lee Puey Ngee


Group DirectorDr Diana Teo

GROUP DIRECTOR’S OFFICEDirector, Blood Service OperationsMs Koh Geok Tin

Senior Manager, Capability DevelopmentMs Leou Kwee Kim

Senior Manager, QualityMs J Thilakavathi

BLOOD SUPPLY DIVISIONDeputy Division DirectorDr Tan Hwee Huang

Acting Branch Director, Blood ResourceMs Toh Ching Lian

Acting Laboratory Director, Blood Supply ManagementMs Sally Lam

Senior Laboratory Manager, Blood Supply ManagementNg Kok Quan

PATIENT SERVICES DIVISIONDivision DirectorDr Mickey Koh

Acting Laboratory Director, Immunohaematology &Cell Therapy SupportDr Marieta Chan

Senior Laboratory Manager, Immunohaematology &Cell Therapy SupportMs Phang Chew Yen

BLOOD SERVICES GROUP

L to R:Ms J Thilakavathi • Ms Leow Kwee Kim• Ms Sally Lam • Ms Koh Geok Tin • Dr Mickey Koh • Dr Marieta Chan• Dr Tan Hwee Huang • Ng Kok Quan • Ms Toh Ching Lian • Ms Phang Chew Yen


Dr Paul Chui

GROUP DIRECTOR’S OFFICESenior Scientific AdvisorProfessor Bosco Chen Bloodworth

FORENSIC MEDICINE DIVISIONDivision DirectorDr Paul Chui

1 Director, Forensic Medicine Operations BranchDr Cuthbert Teo

2 Director, Forensic Medicine Operations BranchDr George Paul

Director, Professional Practice BranchA/Professor Gilbert Lau

FORENSIC SCIENCE DIVISIONDivision DirectorDr Michael Tay

Director, Forensic Chemistry & Physics LaboratoryMs Lim Chin Chin

Director, Forensic Biology Laboratory &Director, DNA Database LaboratoryMrs Tan Wai Fun

ILLICIT DRUGS AND TOXICOLOGY DIVISIONDivision Director &Director, Analytical Toxicology LaboratoryDr Lui Chi Pang

Director, Illicit Drugs LaboratoryDr Angeline Yap

Director, Analytical Toxicology LaboratoryDr Yao Yi Ju

PHARMACEUTICAL DIVISIONDivision Director &Director, Pharmaceutical LaboratoryMs Low Min Yong

Director, Cosmetics Laboratory &Director, Cigarette Testing LaboratoryMs Cheah Nuan Ping

FOOD SAFETY DIVISIONDivision Director &Director, Food Safety LaboratoryMs Joanne Chan

CHEMICAL METROLOGY DIVISIONDivision DirectorDr Lee Tong Kooi

Director, Chemical Metrology LaboratoryMs Joanne Chan

APPLIED SCIENCES GROUP

L to RFront:• Dr Michael Tay • Dr Lee Tong Kooi • Ms Low Min Yong • Dr Lui Chi Pang • Dr Yao Yi Ju Back:• Dr Angeline Yap • Ms Lim Chin Chin • Ms Joanne Chan • Dr George Paul • Mrs Tan Wai Fun • Dr Cuthbert TeoAbsent:• A/Professor Gilbert Lau • Ms Cheah Nuan Ping

Streamlining for Greater SynergiesTo enable us to respond more nimbly to business challenges as wejourney ahead, we restructured our professional and corporate groupsin August 2008 to further streamline our operations and promotesynergies across the organisation. This move marks the completionof an organisational review initiated since 2007 to enhance greatersynergies and collaboration of our professional groups and CorporateHQ, and across HSA as a whole.

With the restructuring, the professional centres were removed andare now reorganised as functional divisions comprisingbranches/units/laboratories under the three consolidated professionalgroups: the Health Products Regulation Group, Blood Services Group(previously known as the Health Services Group and renamed tomore accurately reflect its functions as the national blood service),and the Applied Sciences Group.

The Corporate HQ structure was streamlined in January 2009 fortighter operational effectiveness to enhance its value in definingstrategic direction and providing corporate support for the organisationand its three professional groups.

The Strategic Planning, Operations and Communications Divisionwas formed to better rationalise the functions across the Operationsand Strategy Department, and Planning and Development Department,and also to incorporate the organisation’s Corporate Communications

capabilities. The Human Capital and Legal Division was formed toreflect the emphasis in people development and capacity-building,as well as Organisational Development, to help drive HSA’s strategicdirection and objectives.

A restructuring of the roles and functions of the Quality ManagementOffice was effected. This enables a more holistic approach tomanaging customer feedback and interfaces feedback, and drivingoverall service outcomes to achieve organisational excellence. Inorder to enhance HSA's health and safe workplace initiatives, aWorkplace Health and Safety Department was also established.

A Winning Workplace and WorkforceFollowing an integrated assessment by SPRING Singapore in mid-March 2009, HSA was awarded the Singapore Quality Class (SQC).We also received renewals of the People Developer (PD) and SingaporeInnovation Class (I-Class) awards.

The conferment of these awards is a major milestone for HSA. Thisvalidates our efforts in enhancing overall organisational excellenceand promoting innovation as a key driver to improving work processesand customer responsiveness. Through the PD award, we are alsoheartened to receive recognition for putting a priority in creatingan environment for our staff to grow and make the most of theirtalents and careers. These awards will be invaluable as we gear upand benchmark ourselves for even better performance going forward.



Our Corporate Headquarters (HQ) draws together the scientific perspectives and expertise from ourthree professional groups, and provides both leadership and administrative support to drive these insync with the strategic directions charted for the organisation. It is the effective coordination anddrawing together of the diverse skill sets and ideas across our organisation that will determine howsuccessfully we can meet our national and global commitments today, and provide us the impetus to

expand our public health responsibilities and provide thought leadership for tomorrow.

Inspired by InnovationWe continued to strengthen the innovation culture andencourage the contribution of innovative ideas to drive valuecreation within the organisation.

This was especially evident through the ramping up of ourresearch initiatives to advance innovation and thoughtleadership in diverse areas. Our aim is for our research tocontribute to best practices within the global forensic, scientificand biomedical communities, and also serve to advancescientific boundaries and human health. Key projects in theline-up will focus on developing innovative regulatory practices,building new scientific and forensic capabilities, and exploringnew technologies in blood safety and quality. We signed aMemorandum of Understanding (MOU) with the NationalHealthcare Group’s Domain Specific Review Board to provideus with additional insights as an independent ethics evaluatorfor our research projects. This MOU will help to facilitateHSA’s efforts to continue conducting biomedical researchactivities in a transparent and stringent manner in accordancewith the highest ethical standards.

Several cross-functional project groups and taskforces werealso created to generate high value ideas that are directlylinked to key corporate objectives. Mechanisms and recognitionsystems for staff members to contribute suggestions werealso reviewed. The improvements done were to make it easierfor staff to encourage the generation of quality ideas.


Capabilities Augmented by TechnologyThe year saw HSA further leveraging on and optimising our IT resourcesto accelerate our responses to new business opportunities and delivermore effectively on our core responsibilities. By integrating and expandingour applications and systems, we significantly improved our operatingefficiencies and attained better customer service delivery standards.

Several key business-friendly improvements were made to our licensingsystem, PRISM, to provide us with even greater bandwidth to respondpromptly to the regulatory and licensing needs of businesses. Theenhanced system now allows companies to transact with us electronicallyfor online applications and amendments, automatic renewal of licencesand progressive payments. We will continue to fine-tune PRISM so asto further rationalise our existing work processes and improve ourcustomers’ experience in this core area of our regulatory business.

The FIONA (Forensic Integrated Operations Network Applications) systemcame into full swing at the Mortuary@HSA. With real-time data capturingat source now possible, work processes at the Mortuary@HSA havebeen further streamlined and expedited.

At our Applied Sciences Laboratories, work efficiency and service levelsto our clients moved up several notches with the implementation of theLISA (Laboratory Integrated Scientific Administration) system. With LISA,all laboratory processes are now fully automated end-to-end and clientscan also receive email or SMS notifications when their reports are readyfor collection.

We have also brought the benefits of the Internet to our blood donorsin more ways through the DonorCare system - they now have a time-saving option to fill in their health questionnaires online before visitingthe Bloodbank@HSA for their donations.

The HSA-wide KEN (Knowledge Enterprise Network) was officiallylaunched during the year. Apart from being a rich repository of informationto promote good knowledge management and sharing practices, its newmedia tools such as forums and blogs create an interactive platform forstaff to share tips and information on work-related and recreationalissues. This in turn helps to enhance the innovation climate for crosslearning and sharing.


We are also gearing up for the full rollout of CREST (Collaborating[for a] Reliable, Efficient, Shared System, Together) in the laterpart of 2009. Jointly developed by HSA with our four partneragencies, the Health Promotion Board, Media Development Authority,National Library Board and SPRING Singapore, CREST will enablegreater integration of information to facilitate faster and better-informed decision making to enhance our human resources, financeand administration functions. This effort to develop a sharedsystem will allow all CREST agencies to enjoy greater economiesof scale.

Moving ahead, a key priority will be implementing several keyinitiatives under our new IT Master Plan that will significantlysharpen our capabilities in our regulatory mission. This includesthe development of a new real-time system that monitors theblood inventories of hospitals and a Unique Health ProductsIdentifier (UHPI) system that aims to develop unique codes thatwill be used at the national level to identify specific drugs andmedical devices in the healthcare cluster. Our overall IT infrastructurewill also be revamped to include new equipment and greenertechnology.

Delighting our CustomersVarious structured platforms were introduced to better engagewith our customers and industry partners. These include regularmeetings between clients and industry associations and the HSAmanagement to gather inputs and to better understand theirconcerns. Through these interactions, we are better able to ensurethat our practices and polices are parallel to changing businessneeds and are also market sensitive.

A Customer Satisfaction Survey was commissioned in mid 2008 tounderstand how we can better respond to our customers and alsoimprove our service delivery standards. Further enhancementswere made on the curriculum of the service quality training forstaff to equip them with the relevant skills required in managingcustomer interfaces and to deliver good customer service. Twoin-house awards were launched to recognise staff for their servicedelivery and to identify role models of excellent service toinspire others.

Putting the Public at the ForefrontWe remained committed to providing clear, timely and authoritativeinformation to the public on safety issues related to health productsthrough media releases, alerts and advisories. By creating a heightenedpublic awareness and deeper appreciation of HSA’s roles andresponsibilities as a regulator in an increasingly complex environment,we continued to strengthen relationships with the media andcommunity by reinforcing the importance of the need for the publicto be our co-partners in protecting public health.

A new segment within our corporate website was developed speciallywith consumers in mind. This project is a significant step forwardin our outreach efforts to empower consumers with information onthe responsible use of health products. It features write-ups on HSA’sresponsibilities such as our regulatory philosophy and what thismeans for consumers in layman language, and also contains usefulguides presenting consumer-friendly safety tips on reducing the risksassociated with products ranging from cosmetics to prescriptionmedicine. The segment also houses a microsite on informationrelated to illegal health products and advice on the steps the publiccan take to protect themselves and their loved ones.

Apart from enjoying positive media coverage through variousprominent feature stories profiling our key role as a champion forpublic health and safety in the major dailies, the intriguing workand outstanding capabilities of our forensic medicine and forensicscience teams were also featured in an exclusive episode of UnexpectedAccess, a highly popular prime time Mediacorp television series.



International Alliances that WorkRecognising that the challenges and opportunities encountered bynational regulators of health products are similar across the globe,HSA continued to build on the firm partnerships with our overseascounterparts. Through these strong networks, we hope to generategreater efficiency and innovativeness in managing these challenges,as we share resources and leverage on systems to strengthencapabilities and synergies.

HSA hosted the 3rd Summit of Heads of Medicines Regulatory Agencieson 3 and 4 December 2008. This provided a platform for regulatoryagencies from some 20 countries to engage in dialogue on issues directlyrelated to their national responsibilities. These include immediatepriorities as well as future challenges. The forum also aimed to enableagency heads to interact in an informal setting to develop a deeperunderstanding of each other’s work, stimulate new ideas generation,and explore new areas for collaboration. We put in significant effortto ensure that the programme was substantial and fruitful, and thatdelegates had a unique and enjoyable experience of Singapore, borneout by the positive feedback we received on the Summit event.

We inked two more MOUs during the course of the year – one withSweden’s Medical Products Agency in November and another withthe Medicines and Healthcare Products Regulatory Agency, UnitedKingdom in December. These collaborative arrangements – togetherwith those earlier established with our other MOU partners includingthe US Food and Drug Administration, Health Canada’s HealthProducts and Food Branch, Australia’s Therapeutic GoodsAdministration, China’s State Food and Drug Administration, andSwissmedic – will continue to pave the way to improve the safety,quality, and efficacy of health products marketed in each country.

During the year, we also launched projects within our RegulatoryWorksharing Grouping comprising the Therapeutic Goods Administration,Health Canada, Swissmedic and HSA. These included managing thequality and integrity of supply chain through joint inspections, buildingup post-approval pharmacovigilance efforts through adverse effectsmonitoring, and implementing a staff exchange programme.

We are honoured to have been selected to co-host the 14th

International Conference of Drug Regulatory Authorities (ICDRA)with the World Health Organisation (WHO), in Singapore from6 to 11 September 2010. As one of the major conferences involvinghealth regulators around the globe, ICDRA has been held since 1980with the aim of promoting exchange of information and collaborativeapproaches to health issues of common concerns. We are proud tobe involved in playing a major role in facilitating the discussionsand decisions to be made at this platform, which is an importantconsultative forum for WHO and drug regulatory authorities in theirefforts to harmonise regulation and improve the safety, efficacy andquality of medicines.

HSA’s increasing involvement on the global stage reflects our roleas a valued global partner on the international scene. The allianceswith our global partners endorse our capabilities and expertise asa trusted regulatory body. Through the exchange of knowledge andbest practices, we can better anticipate issues, and make swifterdecisions to fulfill our core mission to protect and advance nationalhealth and safety effectively.

We are now in the midst of exploring the establishment of a centralisedacademy set-up that will add significant value to the organisationby consolidating, supporting and developing our training, researchand thought leadership capabilities, and enable us to make greatercontributions to the international community.

Powered by PeopleBuilding a workforce that is competent, resilient and engaged byattracting, developing, motivating and retaining core employeesremained at the centre of all our people policies during the year. Thisis because we recognise that our success as an organisation is a keyoutcome of the optimal match between each employee’s professionalgrowth, personal goals and our business goals.

We introduced new schemes of service to create a more holisticpeople management system that enhances career progressionopportunities for staff. Our performance management system wasalso revamped to place a greater emphasis on the staff’s individualperformance and competencies. This tied in with a new compensationframework which was finetuned for greater alignment withmarket practices.

In line with our core value to Develop our Community, we remainedcommitted to investing in our people through a comprehensive rangeof training programmes. The learning experience at HSA continuedto be a systematic focused process that takes into account businessgoals and objectives and the skills needed by staff to meet the challengesof the changing environment around us. All officers were given manyopportunities throughout the year to sharpen and enrich their skills,knowledge and competencies, to take them further in their currentroles or to take on new ones within the organisation.

The HSA Professional Board was formed in January 2009 to adviseand make recommendations to the CEO on issues relating to professionalstaff development and professional excellence. The Board is chairedby Dr Diana Teo, Group Director of the Blood Services Group, andcomprises advisors and members of staff from different scientific fieldssuch as science, pharmacy, medicine and nursing. Its key prioritiesinclude further sharpening the strategic skills and competencies ofour staff with a longer-term aspiration to develop HSA into a renownedmedical, scientific and regulatory education, training andresearch centre.

Because we believe firmly that a supportive and welcoming workculture plays a big part in motivating staff to give of their best to theorganisation, the HSA Recreation Team worked hard to present an

exciting menu of activities to all staff. From fitness walks and movienights to anniversary parties, these successfully injected not only morefun, but created a stronger sense of unity and community within theHSA family.

We continued to cultivate meaningful relationships amongst colleagues.Our staff members participated in regular dialogues and meet-upsessions with management. We are also working towards a CollectiveAgreement between the management and staff union to signify thecommitment from both sides in building a people-centred organisation.

Our exemplary efforts in supporting staff development and well-beingwere recognised in more ways than one. Apart from being recertifiedas a People Developer organisation, we bagged the Singapore H.E.A.L.T.H.Gold Award for the third time in recognition of our policies in promotinghealthy workplace practices among our staff. We also received theMinister for Defence Award and the Home Team NS Award(Commendation) for the support given to our officers to be away fromwork because of National Service duties.

Beyond our MissionBesides delivering on our core responsibilities, HSA is committed tomaking a positive difference to our community and environment aswell. This promise was renewed during the year through a review ofthe framework and policies relating to our Corporate Social Responsibility(CSR) framework. The revised CARE Framework, as defined throughits acronym for “Community Action, Responsible for our Environment”,is aimed at developing a caring culture among all staff and encouragingthem to contribute to various social causes in our community.

Various programmes were organised during the year to encourageactive volunteerism among staff. These included HSA’s own blooddonation drives and various fund raising projects for the CommunityChest as well as victims affected by the Sichuan earthquake in Chinaand the cyclone in Myanmar. We also lent our support to programmesorganised as part of the Yellow Ribbon Project, and conducted severalrecycling and energy conservation drives. Our CSR-oriented mindset,which is inherently embedded in our mission of protecting andpromoting public health, will continue to be an integral part in thebusiness decisions we make.



On Track Towards a More Robust Regulatory SystemThe past year saw new requirements under the Health Products Act coming into effect for medical devices andcosmetic products as part of the ongoing roll-out of their respective regulations. These were the first two groupsof products brought under the the new Act after it was passed by Parliament in February 2007.

The Health Products Act serves to amalgamate the existing controls for regulating health products, which currentlyreside in various pieces of legislation, into one omnibus Act. When it comes into full effect, the Act will providemore flexibility for tailoring regulatory mechanisms for specific product groups, as well as strengthened powersfor post-market monitoring and enforcement.

Moving forward, we plan to bring other groups such as complementary health products and therapeuticpharmaceutical products under the ambit of the Health Products Act. As part of the rollout, we will consult andcommunicate with our stakeholders, and also adopt a phased approach in the implementation for the smoothesttransition possible for businesses. In the past year, we were sensitive to the economic downturn and adjustedthe implementation measures or offered appropriate assistance to mitigate the impact on companies. These plansare all part of the ongoing efforts to develop a more robust regulatory system necessary to better protect, andensure safer, higher quality products for our people.

Medical Devices Safety EnhancedThe regulation of medical devices is being implemented in three phases. Phase 1, which started from 1 November2007, requires dealers to report all adverse events to HSA, notify us regarding voluntary product recalls and keepproduct movement records. We commenced Phase 2 in November 2008. We now accept applications for theproduct registration of medical devices, and the licensing of importers, wholesalers and manufacturers has takenplace. Industry briefings, workshops and several training sessions were conducted to familarise our industrypartners on our new regulatory guidances. We also worked with Singapore Accreditation Council to certify thirdparty certification bodies that can perform audit and certification of Good Distribution Practices for MedicalDevices (GDPMDS). The objective of GDPMDS standard is to provide a quality system for maintaining the qualityof medical devices throughout the distribution chain.


The Health Products Regulation Group of HSA not only keeps in step with the wide spectrum ofglobal trends in development and technological advancements in medical drugs and devices, but isalso actively involved in defining new regulatory frameworks and pursuing new areas of research in

regulatory science. This is what enables our regulatory group to ensure that health products in Singaporemeet internationally benchmarked standards of safety, efficacy and quality, but can also begin to pioneerinnovative regulatory approaches that can serve as models for other smaller regulators who need to

optimise the resources and expertise available to them. We recognise the challenges in this role, withchanges around us taking place at an astounding pace. However, through our scientifically soundpre-and-post market regulatory processes and firm collaborations with other local and overseasagencies that share our mission, we have greater impetus to create the best outcomes for all -

be they consumers or businesses whose products we regulate.

A Closer Watch over Cosmetic ProductsThe ASEAN Cosmetic Directive (ACD) has been implemented in all ASEANMember States except Myanmar and Indonesia. Under the ACD which setsthe regulatory requirements for cosmetic products sold in Singapore and otherASEAN member countries, dealers are required to notify HSA before importingany cosmetic product and making it available for sale. This facilitates thecreation of a full database of all cosmetic products in Singapore which inturn enables HSA to implement responsive post-market procedures to effectswift recall of unsafe products from the market.

Companies benefit from the simple and fast notification process, and canlaunch products immediately after notification, so long as they ensure thatthe safety and quality of products conform to international standards. Ontheir part, consumers can enjoy quicker access to safe and quality cosmeticproducts and wider choices. At the same time, they are also better protectedthrough post-market surveillance initiatives under the ACD such as adverseevents reporting, targeted periodic sampling and testing, proper labelling,documentary evaluations and global alerts.

Singapore hosted the 11th ASEAN Cosmetic Committee (ACC) Meeting inNovember 2008. The session discussed updates on the implementation andenforcement of the ACD and the latest developments in ASEAN EconomicIntegration, and agreed on proposals from the ASEAN Cosmetic ScientificBody (ACSB). Singapore, as the lead country also updated the meeting on theASEAN Cosmetic Reference Laboratories (ACRL) Network and the ASEAN Post-marketing Alert System.

Manufacturing Standards Across ASEAN AlignedWe participated in the ASEAN Consultative Committee for Standards & QualityPharmaceutical Product Working Group (ACCSQ PPWG) Meeting held in July2008 during which several key decisions were made. The meeting agreed onthe full implementation of the ASEAN Common Technical Dossier (ACTD) inJanuary 2009, marking a significant milestone in regional harmonisationefforts in the pharmaceutical sector. A common technical dossier format willnow be accepted by all member states for drug registration purposes. Anotherkey achievement was the finalisation and subsequent signing of the SectoralMutual Recognition Arrangement (MRA) on Good Manufacturing PracticeInspection. This is a key step towards ensuring internationally-recognisedmanufacturing standards of pharmaceuticals in ASEAN.



With Business Needs in MindCreating a positive experience for businesses transacting with usremains a prime consideration as we refine our policies and practices.We commenced a major Business Process Review (BPR) in January2009 to review and redesign key regulatory processes. This is withthe broader objective to enhance efficiency, clarity, consistency andcustomer-friendliness in our work procedures. Inputs from stakeholdersincluding the Ministry of Health, healthcare practitioners, industryand overseas health products regulators were taken into accountduring the review, which is expected to be completed by the thirdquarter of 2009.

Several initiatives have been implemented resulting from thepreliminary review. In February 2009, a new office to address theunique needs of Small and Medium Enterprises (SMEs) was set-up.The SME Office seeks to be a one-stop centre offering SMEs assistanceon submission matters and provides these companies with additionalsupport in regulatory affairs. It is staffed by a pool of specially trainedClient Liaison Officers, most of whom have professional backgroundsin various scientific fields, and who also possess a sound understandingof all our regulatory requirements. Our officers personally attend toour SME clients’ concerns on technical issues, advise them ondocumentation requirements and provide a single point of contactfor all matters pertaining to their respective submissions.

We organised a series of regular meetings with industry partners atvarious levels - from line managers to CEOs - to explain our newregulatory policies and decisions, and also to seek feedback andresponses on upcoming plans. An industry newsletter HSA Connectshas been introduced to keep industry stakeholders updated on ourvarious new initiatives and ongoing regulatory news. To complementthis, we conducted workshops to familarise businesses with theregulatory requirements needed when making submissions andupcoming policy changes. The sessions provided a useful forum forcompanies to discuss and clarify on our regulatory processes andtechnical issues, thus reducing uncertainty on steps needed forproduct submissions.

Keeping in close touch with our stakeholders such as companies,industry associations and other service partners has enabled us todevelop processes that are more enterprise-centric, transparent andin tandem with the business climate.

In view of the current downturn, we have put in place a ProgressivePayment Scheme which lowers the upfront cost of product approvalfees for companies. Under this scheme, evaluation fees for medicalproducts are paid in four installments and each installment is paid onlywhen the product advances to the next stage of the evaluation process.

We also implemented a new auto-renewal system for product licencesduring the year. Converting the system to an opt-out one means thatcompanies need only indicate which licences they do not wish to renew.This improvement resulted in considerable time savings and greaterconvenience for companies who have many product licences to maintainas they no longer need to submit annual renewals.

In March 2009, HSA received a Commendation Award in the 2nd

Frontier Licence Review Award organised by the Ministry of Tradeand Industry for the proposal to revamp its licence review frameworkto reduce costs and administrative effort on the part of companieswhose products we regulate. The merits of the proposal include therecommendation of converting the most number of licences tolifetime licensing (10 licences in total).

As part of our commitment to constantly improve in our role as anational regulator, our priority will be on strengthening our capabilitiesin conducting risk assessments of new health products. This willallow even more timely evaluations and approvals of medicallyneeded health products.

Strengthening Risk ManagementIn spite of our best efforts to ensure that health products are as safe as possible before being placedon the market, we recognise that no product is 100 per cent safe. Our risk-based post-market systemto sample and test products from the shelves, complemented by our Adverse Drug Reaction (ADR)Monitoring Programme enabled swift corrective responses when safety concerns came to light. The ADRMonitoring Programme, drawing on a network of local healthcare professionals to report productswhich caused unwanted and unexpected effects, was effective in tracking and identifying safety trends.

The number of local spontaneous ADR reports reviewed by HSA increased from 1,740 in 2007 to 3,155in 2008. Amongst the ADR reports received in 2008, about 55% were serious. 17 adulterated productswere detected via ADR reports in 2008.

We moved up the World Health Organisation’s (WHO) ranking of ADR reports per million from14th position in 2007 to 10th position in 2008. This reflects that our ADR reporting system is robust andamongst the world’s best, in which our healthcare professionals are proactively reporting ADRs theyobserve in their practice. This in turn helps us to pick up safety signals from the local use of marketedproducts more efficiently, and facilitates quick recalls if needed.

We made information on emerging safety issues more readily available and easily accessible to healthcareprofessionals through our Adverse Drug Reaction News Bulletin to increase the awareness of ADRs andpromote ADR reporting. This publication has been accredited by the Singapore Medical Council, theSingapore Dental Council and the Singapore Pharmacy Board, for Continuing Education points. Thisencouraging move reflects the healthcare professional fraternity’s appreciation of the publication’squality. It is also testament of the fraternity’s recognition that keeping abreast of drug safety issues isessential for professional knowledge and healthcare practice.

We further enhanced our review of risk management plans (RMPs) submitted by product licence holdersas part of the life cycle approach to minimise the risks associated with new products. From the periodJune 2008 to May 2009, we reviewed about 20 RMPs that were submitted either at pre-market evaluationor post-market stage, including Revlimid®, Yondelis® and Exjade®. Some of the regulatory actionsresulting from the review of the RMPs included safety updates to the product insert and the submissionof safety reports to address potential safety concerns not identified at the point of product registration.

Last year, we initiated the recall of 22 health products from the market. These came from various productgroups, including pharmaceutical products, Chinese Proprietary Medicines and health supplements. Fiveof these products were recalled as they were adulterated, while the remaining ones were found to beunsafe because they were out-of-specification.

Going forward, we will continue to strengthen our risk management tools, to better manage risk ofhealth products throughout their life cycles. Efforts in risk communication to healthcare professionalswill be stepped up, through early warnings of emerging or potential drug safety problems and promotingsafer use of drugs and health products.



Our Unwavering StanceOur enforcement efforts against illegal health products were steppedup during the year through more intensive surveillance operationsand intelligence gathering. Through more than 2,500 investigationsconducted, about 10,600,000 units (comprising dosage forms oftablets, capsules, liquids and creams) of counterfeit and unregisteredhealth products were seized. Assuming an estimated street value of$2.50 per tablet, the seizures amounted to about $26,504,800.

We took our fight against illegal health products to the global frontas well. We participated in the 3rd General Meeting of the WorldHealth Organisation’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) in Tunisia in December 2008.Singapore, together with the rest of the members of the IMPACTPlanning Group, was re-nominated into office by the assembly foranother two years. WHO launched IMPACT in 2006 to combat theglobal problem of counterfeit pharmaceuticals. Bringing togethernearly two hundred countries, as well as organisations with expertisein enforcement, manufacturing, and patient advocacy, IMPACT hascalled attention to the commercial and public health costs ofmedicines that are deliberately and fraudulently mislabelled andoffered a global forum for discussing solutions. This latest meetingagreed on a revised version of the term “Counterfeit Medical Product”.This new text will provide greater clarity and transparency in differentiatingand addressing various contentious issues raised by members.

We hosted the 11th Permanent Forum on International PharmaceuticalCrime (PFIPC) Meeting from 2 to 5 June 2008. The closed-doorsession was attended by representatives from more than 14 membercountries and organisations from the USA, UK, Australia andSwitzerland. This included presentations, information exchanges anddiscussions on the latest trends in pharmaceutical crime activity andenforcement related issues on dealing with increasing sophisticationof such activities.

In partnership with the PFIPC, we conducted a coordinated operationagainst illegal websites selling medicines over the Internet on12 November 2008, which was designated International InternetDay of Action. The main objective of this coordinated sweep was totake action to prevent and tackle deceptive marketing practicesthrough a global initiative. The global and borderless nature of theInternet and the ease with which illegal medicines can be boughtand sold in different countries around the world pose a threat topublic health. Such coordinated international efforts demonstratean international will to tackle the Internet problem, and are consideredmost strategically effective in addressing this public health challenge.

In our efforts to curb the supply of tobacco products to underagesmokers, we apprehended over 60 sellers who sold tobacco productsto underage youths. A total of 6,662 underage smokers were caughtduring the year. Together with the Health Promotion Board, weproduced a Tobacco Retailer Educational Toolkit to assist tobaccoretailers in Singapore to better comply with the law governingtobacco products and to adopt the "best practices" to avoid sale oftobacco products to underage customers.


Sharpening CapabilitiesTo deepen and broaden our pharmacogenetics knowledge, and in turn, boost our capacityfor advancements in drug regulation and safety, we commenced work on a project tocreate an innovative surveillance network to quickly capture serious ADRs that shouldbe investigated for possible pharmacogenetics linkage.

The project, which will establish the necessary infrastructure and frameworks inpharmacogenetics, will bring about immediate benefits such as reducing the risk of ADRsthrough the identification and/or validation of genetic associations and in the longerterm, facilitate the development of an innovative post-marketing system. It will alsoenable the efficient management of pharmacogenetic data submissions for new drugapplication or product label updates.

The groundwork for this project was established with the formation of an operationalgroup within HSA working in collaboration with a network of research facilities andhospitals. This network will facilitate the collection of patients’ samples and clinicalhistories arising from targeted ADRs. We built a network of collaborations and partnershipswith researchers and clinicians for the analysis and interpretation of pharmacogeneticassays, and convened a Pharmacogenetics Advisory Committee to advise HSA in theseefforts. We also participated in international activities that have similar goals to sharedata and to glean information about polymorphisms in Asian populations.

Powerful PartnershipsHSA strives to be synonymous with partnerships. We are keenly aware that the challenges facing regulatory agenciestoday cannot be addressed single-handedly by any one organisation, but through joint efforts. This is why we valueevery opportunity to learn from others, and in turn bring into these collaborative arrangements our cross-disciplinaryperspectives. Only through partnerships can we be strong today and even stronger tomorrow as we pursue our missionwith vigour.

We were included as a member of the Global Co-operation Group (GCG) for the International Conference forHarmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and participatedin our first conference in June 2008. The focus of ICH has been on the technical requirements for medicinal productscontaining new drugs and comprises regulatory and industry members from Europe, Japan and the USA. The GCG isa sub-committee of the ICH Steering Committee and includes members from non-ICH regions. Our induction intothe Group is recognition of our role as an active contributor in drugs development and regulatory standards.

We continued our efforts to broaden our global network and strengthen co-operation with regulators internationallythrough the signing of Memoranda of Understanding (MOU) with the Medical Products Agency (Sweden), and theMedicines and Healthcare Products Regulatory Agency (United Kingdom) during the year. The scope of the MOUsencompasses mutual exchanges and scientific collaborations spanning a range of work areas. These include therapeuticproducts evaluation, establishment inspection, adverse events investigation, worksharing on pharmacovigilanceactivities, expertise in IT information and management, and training and development. The MOUs formalise the strategicalliances and co-operation between HSA and our regulatory counterparts, and create opportunities for us to leverageon the abilities of collaborating authorities to make timely, effective and scientifically sound regulatory decisions.

We also saw successes in our collaborative arrangements with our other MOU partners - including the US Food andDrug Administration, Health Canada’s Health Products and Food Branch, Australia’s Therapeutic Goods Administration,China’s State Food and Drug Administration, and Switzerland’s Swissmedic. These were through the areas of productevaluations, pharmacovigilance, Good Manufacturing Practice inspections and staff exchange programmes.

Potential new partnerships were explored as well. We hosted a visit in March 2009 by Dr Tatsuo Kurokawa, a Professorfor Pharmaceutical Development at Chiba University, Japan and previously the Japanese representative to the ICHSteering Committee. During his stay, Dr Kurokawa shared from his experience on pharmacovigilance activities andglobal drug development initiatives in Japan, and also heard from HSA and external stakeholders such as the NationalHealthcare Group and the Economic Development Board on Singapore’s progress in these areas. Through this visit,bilateral relations between both countries were strengthened and new possibilities for future opportunities forcollaboration with Japan were created.



* as at 31 March 2009** from 1 November 2008 to 31 March 2009*** from January to December 2008**** includes new, renewal and amendment applications

KEY STATISTICS

New ProductLicences Issued174174

RegisteredMedicinalProducts*5,3895,389

CosmeticProducts Notifiedunder ACD*108,200108,200

ChineseProprietaryMedicines Listed8,5798,579

Site Audits Conducted forGood Manufacturing& Good DistributionPractices(April 2008 – March 2009)

520520

Premises, Dealersand Importers &Exporters of HealthProducts Licensed/Certified********(April 2008 – March 2009)

3,5403,540

Authorisation Lettersfor Travellers BringingPersonal Medicationinto Singapore(April 2008 – March 2009)

1,0311,031

SpontaneousAdverse DrugReaction ReportsReceived***17,36717,367

Total Numberof Units (Tablets /Capsules) Seized10,601,92010,601,920

Tobacco RetailOutlets Licensed*5,7685,768

Underage YouthSmokers Caught6,6626,662

Clinical TrialsCertificatesGranted***286286

MedicalAdvertisementPermits Issued2,0892,089

Number of ProductRegistration Applicationsfor Medium and HighRisk MedicalDevices**334334

Number of ProductRegistration Applicationsfor Low Risk MedicalDevices**118118


PRE-MARKET ACTIVITIESPRE-MARKET ACTIVITIESEvaluation, Licensing & Certification

Drugs and Biologics

New Product Licences Issued 174Innovators’ Products:

• Chemicals 72• Biologics 40• Generics 62

Variations in Product Licences 2,469• Chemicals 2,120• Biologics 349

Registered Medicinal Products (as at 31 March 2009) 5,389• Prescription-Only Medicines (70.53%) 3,801• Pharmacy-Only Medicines (12.32%) 664• General Sale List Medicines (17.15%) 924

Import of Medicinal Products for Re-Export 2,959Import of Medicinal Products on Named-Patient Basis 4,982Travellers’ Medication Permits Issued* 1,031* Permits issued to visitors bringing in personal medications containing a Controlled Substance

Chinese Proprietary Medicines (CPM)

CPM Listed (as at 31 March 2009) 8,579Number of Product Listing Applications Received 901Number of Rejected Applications 0Number of Licensed CPM Importers* 169Number of Licensed CPM Manufacturers* 25Number of Licensed CPM Re-Packers* 28Number of Licensed CPM Wholesalers** as at 31 March 2009 247

Cosmetic Products

Cosmetic Products Notified 108,200New Cosmetic Product Licences 83,300Total Cosmetic Product Licences 24,900New Importers Licensed 0Cosmetic Products Rejected 270Letters of Free Sales for Export 5

Health Supplements

Enquires on Classification, Import and Sales Requirements 4,488

Medical Advertisements

Medical Advertisement Permits Issued 2,089• Western Medicines 45%• Chinese Proprietary Medicines 21%


Compliance with GMP and GDP - Premises, Dealers, Importers and Exporters

Premises, Dealers, Importers & Exporters Licensed/Certified* 3,540Manufacturers/Assemblers Licences Issued* 120Wholesale Dealer’s Licences Issued* 495Import Licences Issued* 808Export Licences Issued* 182Pharmacy Certificates Issued* 356Form A Poisons Licence Issued* 607Form C Poisons Licence Issued* 552Certificate of Pharmaceutical Products 229Good Manufacturing Practice (GMP) Certificates Issued 33Good Distribution Practice (GDP) Certificates Issued 1Free Sale Certificates 119Statement of Licensing Status Issued 8GMP Clearance for Overseas Manufacturers 70* Includes new, renewal and amendment applications

Clinical Trials (January to December 2008)

Clinical Trials Certificates* Granted 286• Phase I 54• Phase II 61• Phase III 140• Phase IV 31

Clinical Trials Applications Approved 188Clinical Trials by Therapeutic Areas:

• Oncology 32%• Clinical Pharmacology 22%• Cardiology 11%• Neurology 6%• Gastroenterology/Hepatology 3%• Ophthalmology 3%• Others 23%

Initial Reports of Adverse Drug Reactions (ADRs) 2,774Follow-up Reports of ADRs 4,570* a Clinical Trial Certificate is issued for each participating site in a clinical trialNB: More than one suspected drug may be implicated in an ADR report.


Investigation, Surveillance and Prosecution

Total Number of Units (Tablets or Capsules) Seized 10,601,920Complaints Received 2,568Prosecution Cases Completed 62Offenders Sentenced to Imprisonment 35

Adverse Drug Reaction (ADR) Monitoring (January to December 2008)

Total Number of Spontaneous Reports of Suspected ADRs to All Health Products 17,367(Pharmaceuticals, Complementary Medicines & Cosmetics)ADR Reports from Public Hospitals 47.9 %*ADR Reports from Government Clinics 43.3%*ADR Reports from Private Hospitals and Clinics 3.8 %*ADR Reports from Pharmaceutical Companies 4.3 %*ADR Reports from Community Pharmacies 0.7%*ADR Reports Associated with Pharmaceutical Products 89.1 %** Based on 3,155 ADR reports analysed

Top 10 Drugs Suspected of Serious ADRs

Active ingredient No.

1 Atenolol 157

2 Hydrochlorothiazide 116

3 Simvastatin 108

4 Diclofenac 106

5 Metoclopramide 83

6 Coamoxiclav 79

7 Enalapril 77

8 Paracetamol 74

9 Docetaxel 73

10 Cotrimoxazole 65

POST-MARKET ACTIVITIESPOST-MARKET ACTIVITIES


Top 5 System-Organ Classes Affected by ADRs

Active Ingredient No.

1 Skin & Appendages 1,193 (22.4%)

2 Body as a Whole 782 (14.7%)

3 Nervous System 603 (11.3%)

4 Respiratory System 463 (8.7%)

5 Gastro-intestinal System 442 (8.3%)

Tobacco Regulation

Tobacco Retail Outlets Licensed (as at 31 March 2009) 5,768

Tobacco Importer/Wholesaler Licensed (as at 31 March 2009) 63

Exemptions for Advertisement Issued 143

Total Cigarettes Seized 13,726

Complaints of Offences Received 640

Underage Youth Smokers*** Caught 6,662

Retailers Caught Selling Tobacco to Underage Youths 64

Compounding Cases Completed 6,346

Prosecution Cases Completed 472*** Persons under 18 years of age

Medical Devices

Number of Product Registration Applications for Medium and High Risk Medical Devices1 334

Number of Product Registration Applications for Low Risk Medical Devices1 118

Number of Manufacturer’s Licence Applications1 3

Number of Importer’s Licence Applications1 20

Number of Wholesaler’s Licence Applications1 21

Field Safety Corrective Actions (FSCA)2 412

Reported Adverse Events Relating to Medical Devices2 1731 Data for the period 1 November 2008 to 31 March 20092 Data for the period 1 April 2008 to 31 March 2009FSCA are actions taken by the medical device manufacturer to ensure public safety when using a medical device (e.g., product recalls).

Reaching Out to Blood DonorsOur partnership with the Singapore Red Cross for the National BloodProgramme entered its eighth year. The number of blood donors comingforward continues to increase annually, with 60,654 donors making 92,454whole blood and 9,506 apheresis donations in 2008. Donor recruitmentprogrammes focused on the campaign theme of “Are you my type?” thattargeted young people between 16 to 25 years and aimed to entrenchblood donation as an iconic part of their youth culture.

Every year, World Blood Donor Day is celebrated globally to honourvoluntary altruistic blood donors who regularly donate the ‘Gift of Life’to help those in need of blood transfusion. In 2008, World Blood DonorDay was celebrated in Singapore on 14 June with the theme of ”GivingBlood Regularly”. Blood donors were invited to celebrate with theirfamilies and friends at the Singapore Zoo. 1,318 Champion Blood Donorswere honoured at ceremonies held in the picturesque settings overlookingthe lake. 37 bloodmobile organisers were also recognised for theirinvaluable contributions to the community during the ceremonies.

Continuing with our drive over previous years to make blood donationmore convenient, several new initiatives were introduced. To reducethe waiting time for donation, blood donors making blood donationappointments online have the option of completing their pre-donationhealth assessment questionnaires online before coming down to theBloodbank@HSA.

The health and safety of our blood donors remains an importantarea of focus. To protect the iron levels of our blood donors, iron-rich desserts were added to the post-donation refreshments provided.We have also enhanced the care of regular donors with lowhaemoglobin levels, putting in place programmes to monitor theiriron levels and provide counselling on how to improve thehaemoglobin levels.


Blood Services Group

As the national blood service, the Blood Services Group of HSA diligently keeps in focus its critical lifesaving and life giving mission in every aspect of its operations. Quality and safety are guaranteed

through internationally accredited blood bank and transfusion medicine protocols, thus ensuring everypatient access to the safest possible blood supply appropriate to clinical need. To lend further impetusto our commitment to deliver a world-class blood service, we continually strive to achieve the highestlevel of excellence. By judiciously adopting latest knowledge and innovatively adapting new technologies,we maintain our edge in the fields of transfusion medicine, immunohaematology and tissue typing sothat we can continue to deliver blood products and services of the highest standards. At the same time,

we are actively engaged in cutting edge areas of therapeutic research such as cell processing.


Adopting New Technologies to Enhance Blood Supply Safetyand QualityMaintaining stringent and strong quality systems in blood processing, testing,inventory management and distribution remains the top priority of our BloodSupply Management Laboratories. With rapid advances in blood banktechnology, new and improved systems for processing and testing the bloodsupply are continuously made available. By wisely adopting new technologiesthat are appropriate to our blood service and continuously adapting existingprocesses innovatively, we aim to ensure that our national blood supply isefficiently and effectively managed.

New technologies were adopted to ensure that blood donations continueto be screened for blood types and transfusion-transmitted infectiousdiseases using state-of-the-art systems. New protocols to screen blooddonations for malaria were explored to improve the safety of blood collectedfrom donors who had returned from malaria endemic areas. New bloodbag systems incorporating sample diversion pouches were introduced, thusreducing the risk of bacterial infection as well as improving workplacesafety for our staff.

We are also studying the new developments in pathogen reductiontechnology that will enable blood components such as platelets and plasmato be treated to inactivate low levels of viruses, bacteria and parasites thatmay be present. A two-year pilot study is ongoing to assess the clinicaluse of methylene-blue treated fresh frozen plasma. Research projects arealso in progress to study the effectiveness of two types of pathogeninactivation protocols (psoralen and riboflavin) available for platelets.

In addition, much work is taking place to develop effective strategies tomanage the blood supply in the face of emerging threats such as dengue,chikungunya and novel influenza strains. Research was also done to assessthe risk of non-infectious transfusion complications such as TransfusionAssociated Acute Lung Injury (TRALI) and to assess appropriate measures toreduce these risks. Successful strategies must always balance the need toensure patient safety without compromise to the availability of supply andtimely access to blood transfusions when required.

Providing High Quality Immunohaematology and TissueTyping SupportWith introduction of new medical procedures and treatments in ourhealthcare institutions, it is critical to put in place timely and relevantlaboratory and blood transfusion support to assure best possibleoutcomes for the patient. For example, with the introduction ofABO-incompatible kidney transplants in Singapore, ourImmunohaematology Laboratories provided critical laboratory testingto support the treatment.

The Immunohaematology Laboratories also continued to upgradeand expand our capabilities to meet international standards as a redcell reference laboratory. Research projects in the area of molecular-based blood group typing contribute towards the development ofexpertise in this growing area of transfusion medicine.

The Tissue Typing Laboratory continued to provide high qualitysupport to the haematopoietic stem cell and solid organ transplantprogrammes in Singapore, as well as some other countries in ourRegion. To assure that transplant programmes are provided withthe best possible laboratory support, the laboratory introduced newtechniques of HLA antibody detection based on flow cytometry.Even newer technologies involving more sensitive and speedy methodsof antibody detection and identification are also being evaluated,as well as the study of possible genetic sequencing methods for HLAtyping in future.

Collaborations with Clinical ColleaguesAs a reference centre for transfusion medicine, immunohaematologyand tissue typing, we maintain strong links with our hospitals withthe aim of providing patients the best possible care through ourclinical consultative services.

To ensure that blood and blood components are appropriately transfusedfor the correct clinical indications, our doctors worked closely with theirhospital colleagues to develop robust protocols for handling complicatedmedical situations needing blood. Such protocols continue to improvethe speed and effectiveness of blood transfusion support, for example,during liver transplants and obstetric emergencies.

The National Haemovigilance Programme, initiated in 2003 incollaboration with public and private Hospital Transfusion Committees,continued to function effectively to gather local data to assess thefrequency of blood transfusion complications and to enable continuedimprovement efforts to be taken to reduce such complications. Anew initiative has been the inclusion of donor haemovigilance tostudy the complications associated with blood donation.

The Haemovigilance Programme in Singapore is part of wider groupssuch as the International Haemovigilance Network (IHN) and theInternational Society for Blood Transfusion Working Party onHaemovigilance. Through such collaborations, our Blood ServicesGroup is able to compare data and information, as well as toparticipate actively in the development of international standards,definitions and indicators.


Attaining International Benchmarks of ExcellenceWe were proud to achieve accreditation in August 2008 by the American Society for Histocompatibilityand Immunogenetics (ASHI) for tissue typing and transplant support activities. The guiding principleof emphasising excellence in all areas of our work enabled our Tissue Typing Laboratory to attainthis distinction, which is awarded only upon demonstration of the highest standards of reliabilityand quality in Histocompatibility testing laboratories. HSA’s Blood Services Group is one of onlytwo national blood services in Asia to have achieved this accreditation.

The ASHI accreditation follows our international accreditation by AABB (formerly known as AmericanAssociation of Blood Banks) for blood banking activities since 2006. The AABB accreditation for bloodbanking and transfusion activities demonstrates our commitment to advanced learning, continuousimprovement and innovation by striving to sustain the highest possible levels of patient and donor care.

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