Jeewon Joung
Ministry of Food and Drug Safety Republic of Korea
APEC RHSC Biotherapeutic Roadmap Activity
- How to Work Together with Global Initiatives -
I. APEC Biotherapeutic Products
Roadmap
II. APEC Biotherapeutics Workshop
III. How to work together
IV. Conclusion
Outline
2
• Created in 1989, currently with 21 member economies • Goals
– Promote trade, sustainable economic growth and prosperity of member economies through policy alignment and economic and technical cooperation
Activities - to enhance and sustain regulatory convergence and capacity building efforts • Conduct surveys and research • Provide education • Establish strong networks • Support international cooperation
9 Roadmaps (Champion Economies)
1) MRCTs (Japan) 2) Good Supply Chain Practice (US) 3) GRP, 4) Combination products & 5) Good Submission Practice (Chinese Taipei)
6) Biotherapeutics & 7) PV (S.Korea) 8) GCP inspection (Thailand)
9) Cellular Therapies (Singapore)
Role of APEC RHSC Roadmaps
RHSC Roadmaps
Regulatory Convergence
International Standards
Initiated to create the roadmap in line with LSIF strategic plans for the convergence of approaches to the regulation of biological products in APEC economies (Sep 2011, APEC SOM Meeting)
- Korea was designated “champion nation” to establish the roadmap The Roadmap for Biotherapeutic Products was officially endorsed at RHSC meeting (Feb. 2013)
Scope
Among biological products, this roadmap will only cover the area of recombinant DNA products, monoclonal antibody, and therapeutic vaccines. Vaccines, blood products and cell/gene therapy products are NOT within the scope of this roadmap.
Specific Action Plans and Time Frames
8
2019 ~2020
2015~2016
Step 2
Assessment of
regulatory
environment and
gaps between APEC
members through gap
analysis and
workshop
Step1
2017~2018
Step 3
2013 ~2014
Step 4
Training/workshop
Recommendations for
regulatory
convergence
•Establish concrete
training system
•Build up collaborative
system and information
sharing network
•High regulatory
convergence
Assessment &
training/workshop
•Analyze steps 1, 2
•Review post-
implementation of
international
guidelines
•Revise training plans
and continue trainings
to foster experts
Training &
Workshop
•Develop training
curriculum and
conduct training and
workshop
APEC Biotherapeutics Workshop
– A tool for performance ‘APEC Biotherapeutic Products Roadmap’
– Performance
When Where Participants Main topic
1st Sep 2013
Seoul, Korea 368 participants from 15 countries + WHO (Regulators from 10countries)
• ICH/WHO role in standard setting • Clinical, nonclinical and quality of biotherapeutics
2nd May 2014
Seoul, Korea 279 participants from 22 countries + WHO (Regulators from 14 countries)
• Life cycle management • Immunogenicity • Acceptance of foreign clinical data
Analysis of regulatory status in APEC
• Survey conducted to understand the areas of gaps and opportunities for regulatory convergence; 10 out of 21 economies responded (2014.2~5)
• Most responded countries have already either partially or fully implemented the ICH guidelines (9 out of 10)
Eg. Thai FDA has recently implemented Q5E
• Regulatory gap between harmonized and non-harmonized countries may be wide
Prioritization of what is needed for non-harmonized countries should be discussed
Opportunities for Convergence
• Convergence between guidelines – Convergence with guidelines can lead to convergence of
regulation in APEC economies
– Much overlap between WHO and ICH Guidelines WHO guidelines for biotherapeutics and biosimilars were recognized as core guidelines for convergence
• Identified opportunities for convergence in 2014; – Post-approval changes
– Immunogenicity assessment for biotherapeutics and biosimilars
– Acceptance of foreign clinical data (Applicability of ICH E5 to biotherapeutics and MRCT)
Training may be required in these topics for non-harmonized countries
Recommendations to RHSC • Create a mechanism for high level engagement with
policymakers
• Next AHC workshop should delve into the issues around
– immunogenicity of biotherapeutics and biosimilars
– Applicability of ICH E5 to biotherapeutics
– Post approval changes (2015)
• Work to incorporate modules in the ‘Center of Excellence (CoE)’ pertaining to CMC questions in life cycle management and post approval changes
• Excellent initiatives in ICH, APEC RHSC, WHO, ICDRA; Each has its own strength and should be leveraged
2015 Plan: Step 2, Training/Workshop
13
Working Group • Assessment of step 1 and drawing of future strategies •Design of training program - analyzing other training programs such as case studies from WHO as teaching tools - pilot training programs with written, audio, video and presentation formats Training • Small-topic-based training sessions/workshops • Experts from NRAs, industries, academia will be the faculty
2015~2016
Step 2
Training &
Workshop
•Develop training
curriculum and
conduct training and
workshop
14
How to work together
for Regulatory Convergence
• Different starting point and legislation
• Different needs and expertise for authorization in developing countries vs. developed countries
• Interpretation without common language and principles
• Differences in the decision making for marketing authorization on the same clinical data presented to each regulatory authority
Regulatory challenges for biotherapeutics
Challenges for regulatory authorities
• Growing complexity in medicinal products (new chemical entities and innovative products)
• Gaps/vulnerabilities in global regulatory oversight providing opportunities for the tampering and counterfeiting
• Pressures to control and reduce regulatory public expenditures
• Pressure to harmonize and align regulatory practices and activities
• Growing number of international regulatory initiatives, lacking integration and strategic oversight
– Overlapping tasks and exhaustion of resources
MFDS Participation in global initiatives for biological products
International Coalition of Medical Regulatory Authorities (ICMRA)
International Pharmaceutical
Regulators Forum (IPRF)
International Conference on Harmonization
(ICH)
APEC Life Science
Innovative Forum
ICH expert committee
IPRF Working Group
APEC RHSC
Q3C, Q3D, Q7 q&a
S1, S10
E2C, E6, E17, E18
M1, M4E(R2), M7
Biosimilar (Chair)
GCP inspection
Cell therapy
Gene Therapy
GMP Inspection
Safety information
APEC AHC
WHO Collaboration
Mapping existing international initiatives ECBS
ICDRA
Collaborating Center
WPRO Regional alliance steering committee
DCVRN
GMP – coordination of international inspections
International Generic Drug Regulation Pilot
• Development of distinctive roles for each international bodies (or stakeholders) to avoid duplication of work and make best efficient way of collaboration
‒ Identification of possible linkage with existing international bodies is needed
E.g. APEC-WHO back-to back meeting (2014.5)
• Purpose of international collaboration should aim for efficient and timely global development and access to biotherapeutics including biosimilars
• A strong initiative is needed for strategic direction and productive collaboration
Direction for collaboration
WHO ICMRA ICH IPRF APEC
Purpose Standardization of biological products
Global strategic direction from regulatory heads
Harmonization by common regulatory standards
Cooperation and convergence at technical/operational level
Promote convergence and best practices
Roles Development of international guidelines Implementation workshop
Identification of strategic areas of shared need or opportunity
Development of regional guidelines
Regulatory information sharing, Support implementation of global guidelines
Training, Capacity building
Level of task
Strategic Operational
Strategic Operational Operational Operational
No of members
194 20 (incl. WHO)
10 (SC incl. WHO) 14 (GCG)
18 (incl. WHO)
21
Major global initiatives in biotherapeutics
• Objectives: To provide strategic advocacy for a range of areas and actions common to medicinal products regulators and to identify areas for potential synergy
• Background: Established interim in 2013 with 20 member countries including WHO (Chair: Health Canada,
Vice chair: PMDA, HRPA)
• Projects Underway
ICMRA
Projects
Developing Governance and Terms of Reference
Mapping existing initiatives/enablers
Communication strategy concerning the ICMRA
GMP – coordination of international inspections
Generic drug initiative – building on current international pilot
Rapid sharing of information and confidentiality commitment within the ICMRA
Capacity building initiative
Cooperation among global initiatives
ICMRA
ICH
APEC
IPRF
Strategic direction
WHO
Technical Operation
ICMRA -Global strategic direction
Proposed scheme for collaboration in the area of biosimilars
IPRF Biosimilar Working Group - Development of scientific reflection paper and common product assessment
information -
APEC Harmonization
Center - Implementation and training of guidelines -
WHO - Establishment of
international
standards -
MFDS - Interaction
Core -
• Regulatory convergence should be used as a tool to increase global access to biotherapeutics of high quality, safety, and efficacy and to foster global development of innovative product
• Priority should focus on
‒ Need for better understanding of ‘convergence’
‒ Understanding gaps and different environment
‒ Linkages for efficient communication
‒ Collective use of resources
‒ Sharing of information and knowledge
• APEC Biotherapeutic Products Roadmap will play a key role in
‒ Strengthening mutual reliance and synergies
‒ Achieving better use of work products
‒ Sharing of best practices
Conclusions
Thank you
Jeewon Joung Tel +82 43 719 3504 E-mail [email protected]