1 the diversity of safety reporting requirements and systems in asia 2010.05.17 beijing china
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The diversity of safety reporting requirements and Systems in Asia2010.05.17 Beijing China
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Presenter
Jean-Christophe DELUMEAU MD PhD
Head of Pharmacovigilance Asia-PacificBayer HealthcareGlobal R&D Center Asia, Beijing
+86 10 6536 0829 office phone+86 13910420935 Blackberry phone
http://www.linkedin.com/in/delumeau
Disclaimer; The views and opinions expressed in the following slides are those of the individual presenter and should not be attributed to DIA or Bayer Healthcare.
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Harmonization in Pharmacovigilance
ICSR submission requirements
Electronic submission (E2B standards)
Aggregate reports submission requirements
Coding dictionary
Risk Management Plan and Risk mitigation requirements
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Harmonization in PharmacovigilanceICH countries and beyond
ICH Guidelines and MEDDRA dictionary implemented in USA, EU and Japan and more or less followed by other countries
Specific Risk Management requirements Europe USA
Specific ICSR submission requirements e.g. France-specific causality assessment (imputabilite) Spain: Mandatory reporting in Spanish
E2B submission of ICSRs from Global pharma databases USA and Canada All 27 countries of the European Union + Norway, Iceland and Croatia
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E2B systems for ICSR management
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WHO-UMC International Safety Survey
Uppsala Monitoring Center appointed by WHO Preferred ICSR transmission standard: E2B Alternative: old INTIS standard
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High degree of diversity in Asia
Diversity of ICSR submission requirements
Diversity of aggregate reports submission requirements
Only a few countries are requesting RMPs
Most countries are still using WHO-ART
Only Japan is has an E2B safety data base, but E2B-J
Most AP countries are still using INTIS to forward ICSRs to the UMC
Electronic submission is not possible
An increasing number of countries request entering ICSRs into a country-specific web-based system
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Diversity of Safety Systems In Asia
Japan India China Korea Thailand Taiwan Malaysia Singapore Vietnam Indonesia Philippines Hong Kong Cambodia Pakistan
Japan-specific E2B submission mandatory
E2B-Vigiflow implemented in November 2010
Non E2B system – web submission mandatory
Non E2B system – web submission requested
Non E2B system – web system available
No E2B submission – no web system
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Language for domestic ICSR Submission
Indonesia Vietnam Cambodia Thailand Taiwan
Hong Kong Singapore Malaysia India Pakistan Philippines
China Korea Japan
ENGLISH MANDATORY
LOCAL LANGUAGE
MADATORY
ENGLISH and/or LOCAL
LANGUAGE ACCEPTABLE
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ICSR submission requirements in Asia
ICSR submission requirements vary considerably across countries depending upon
Language requested for submission Domestic or foreign case Solicited or non-solicited Seriousness Causality Submission time frame Definition of the clock start Age of the product on the market Reference used for listedness
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Safety submission requirementsEast Asia
DomesticSolicited
DomesticNon Solic.
OverseasSolicited
OverseasNon Solic.
Lingua語
WebSubmiss.
E2BeSub
AggregateReports
RMP
Japan 日本語 No Yes 日本語 日本語Korea 한국어 Mandatory No 한국어 not yet
China 中文 Mandatory No 中文 中文Hong Kong Eng.中文 No No G-PSUR G-RMP
Macao No No
Taiwan Eng.中文 Possible No G-PSUR discussions
Expedited: Global ICSR format acceptable Unavailable or no requirement specified
G-PSUR G-RMP
Expedited: Country-specific ICSR format Specific Specific
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ICSR Reporting requirements Hong Kong
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ICSR Reporting requirements Korea
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ICSR Reporting requirements Taiwan
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ICSR Reporting requirements China
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ICSR Reporting requirements Japan
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Safety submission requirements ASEAN
DomesticSolicited
DomesticNon Solic.
OverseasSolicited
OverseasNon Solic.
English WebSubmis.
E2BeSub
AggregateReports
RMP
Singapore Standard Possible No G-PSUR G-RMP
Brunei Standard No
Malaysia Standard Possible No G-PSUR
Thailand Web Web Accepted Expected No G-PSUR
Indonesia Accepted No G-PSUR
Philippines G-PSUR G-PSUR Standard No G-PSUR
Vietnam G-PSUR G-PSUR Accepted No G-PSUR
Cambodia
Laos
Myanmar
Expedited: Global ICSR format acceptable Unavailable or no requirement specified
G-PSUR G-RMP
Expedited: Country-specific ICSR format Specific Specific
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ICSR Reporting requirements Indonesia
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ICSR Reporting requirements Thailand
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ICSR reporting requirements Philippines
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ICSR reporting requirements Vietnam
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ICSR Reporting requirements Singapore
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ICSR Reporting requirements Malaysia
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Safety submission requirementsSouth Asia
DomesticSolicited
DomesticNon Solic.
OverseasSolicited
OverseasNon Solic.
Lingua語
WebSubmiss.
E2BeSub
AggregateReports
RMP
India English Hospitals No G-PSUR
Pakistan English No No G-PSUR
Sri Lanka
Maldives
Bangladesh
Nepal
Expedited: Global ICSR format acceptable Unavailable or no requirement specified
G-PSUR G-RMP
Expedited: Country-specific ICSR format Specific Specific
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ICSR Submission requirements Pakistan
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ICSR Submission requirements India
2011.05.11: the Central Drugs Standard Control Organization (CDSCO) circulated a new guidance for the reporting of Serious AEs from clinical trials.
Obligation to report within 14 calendar days Causality to be assessed yes/no Obligation to report compensation status in case of death India-specific report form
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ICSR Submission requirements India
New reporting form proposed by the CDSCO
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ICSR Submission requirements India
Categories of clinical trials to be specified in the new reporting form
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Impact of country-specific requirements
ICSR submission from global safety system is possible e-submission: not available in any AP country so far Printed on PDF or paper from the global company safety database
ICSR submission via country-specific E2B system is possible
Submission to the PMDA in Japan ( 日本語 )
ICSR submission via National web system is mandatory China ( 中文 ) Korea ( 한국어 ) Thailand (English acceptable) Concern: more and more counties will make it mandatory
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Impact of country-specific requirements Japan
ICSR submitted electronically to the PMDA (E2B-J standard)
Japan-specific requirements e.g. Japanese language, specific reporting form, specific causality assessment rules
Most companies use a J-specific system e.g. Perceive, Clinical Works in addition to their Global PV system thus duplicating data entry work
Solutions to mitigate the impact
Data transfer bridging applications to minimize duplicating data entry.
Global system perspectives Alice (HP): only global system operating submission to PMDA Aris/Aris-J may be connected Argus/Argus-J (Oracle) not connectable so far but connecting the two platforms may be considered
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Impact of country-specific requirements Korea
All domestic ICSRs must be entered in Korean language
Into the web system Easydrug (except GCP trial cases)
e-submission not yet possible
KFDA is able to forward ICSRs to WHO’s UMC on E2B format
No Korean version of Meddra to map Korean vs English medical terms
Solutions to mitigate the impact Parallel data entry into global system and Easydrug Developing E2B transmission and Meddra capability Need for collaboration between the KFDA, Software providers and Industry
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Impact of country-specific requirementsChina
Domestic ICSRs to be entered in Chinese into ADR center web system
e-submission of ICSRs impossible (Not E2B compatible)
WHO-ART still used although a Chinese version of MEDDRA exists
Causality and Seriousness categories are specific to China Need to submit China-specific aggregate reports Not fully consistent with documents submitted to EMA and FDA
Implications Duplication of data entry work for multinational companiesand Chinese hospitals participating into international safety research
To forward ICSRs to the UMC, the Chinese ADR Center needs to use the old INTIS or convert cases into E2B format
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Impact of country-specific requirementsChina
Revised Drug Affair Law at final stage of approval at Ministry of Health anticipated to be released in 2011 but still awaited
New National ADR center database with web-based facility expected to become available by June 2011
The need to make the replacement Chinese safety database compatible with the E2B world seems now recognized by the SFDA and ADR who are looking for bridging solutions
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Advantages for moving toward E2B
Advantage for Health Authorities Recommended by the WHO-UMC for data transfer Facilitate ontribution to international safety research Enable using advanced signal detection systems e.g Empirica or VigiMine
Larger sample size for signal detection in specific ethnic groups
Advantage for the pharmaceutical industry Avoid duplication of data entry workload Focus resources on signal detection and benefit/risk optimization
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E2B systems for ICSR management
Used by the Pharma Industry e.g. AERS (Oracle) ARGUS and ARGUS-J (Oracle) ARISg and ARISj (Aris Global) Safety-Easy (ABcube) Company-specific (e.g. MSD, AZ etc..)
For Health Authorities e.g. AERS (Oracle) used by the FDA Eudravigilance (EMA-specific) Vigiflow (UMC) used by SwissMedic ARISg used by the French Medicinal Agency Safety-Easy (ABcube)
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E2B solutionsfor National Heath Authorities
ORACLE AERS
Oracle actively promoting AERS for regulatory authorities
For signal detection, following the acquisition of Phase Forward, Oracle is working on integrating Empirica Signal (developed in collaboration with the FDA) into the AERS platform
In a second step, Empirica Signal will be integrated into the Argus platform as Argus Perceptive will be discontinued.
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E2B solutionsfor National Heath Authorities
VIGIFLOW (WHO-UMC) may be set in 3 different ways
ICSRs entered locally and forwarded to the central UMC database
ICSRs entered locally and forwarded to a Country-specific database container maintained by the UMC in Uppsala
Setting a Vigiflow system in the Country (full license needed)
Vigiflow is designed to be customised to local languages The UMC is keen to support interfacing Vigiflow with E2B-
compatible ICSR submission systems of the Pharmaceutical industry
Cost-effective way to open the door to ICSR e-submission in countries with limited budget to purchase and maintain a national safety database
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Diversity of Safety Systems In AsiaNews as of 2011.05.17
India: Vigiflow implemented in November 2010 at the All India Institute of Medical Sciences (AIIMS) to support the Pharmacovigilance Program of India (PvPI). In April, the Ministry of Health appointed the Indian Pharmacopoeia Commission (IPC). IPC will also be using Vigiflow. New requirements for reporting SAEs from clinical trials
China: The National ADR Center is planning to implement a new ADR-reporting web-based system in June 2011. The date of release is not confirmed. This system is not anticipated to be E2B compatible, however the ADR center has decided to look for solutions to bridge their new system with the E2B world
Taiwan: In January 2011, Taiwanese ADR center sent a questionnaire to the Pharma industry inquiring on the benefit for moving to an E2B system
Vietnam: The DI&ADR center is planning to set a locally designed country-specific web-based ICSR reporting system
Singapore, Malaysia, Thailand, Australia, New Zealand are considering acquiring an E2B system but there seem to be no clear decision so far
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Different viewpointsbut sharing similar goals
National Health Authorities
Domestic pharmaceutical companies
International Organisation
Multi-National pharmaceutical Companies
All Pharmacovigilance professionals
Aiming at ensuring the safe use of medicinal agents
Facing Increasing amounts of ICSRs
Dealing with limited resources
Harmonization helps avoiding duplicating work and focusing on Benefit versus Risk Management
Harmonisation for better health (ICH Mission Statement)
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Thank you for your attention