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The%20diversity%20of%20safety%20reporting%20requirements%20and%20Systems%20in%20Asia

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Title: The%20diversity%20of%20safety%20reporting%20requirements%20and%20Systems%20in%20Asia


1
The diversity of safety reporting requirements
and Systems in Asia
  • 2010.05.17 Beijing China

2
Presenter
  • Jean-Christophe DELUMEAU MD PhD
  • Head of Pharmacovigilance Asia-Pacific
  • Bayer Healthcare
  • Global RD Center Asia, Beijing
  • 86 10 6536 0829 office phone
  • 86 13910420935 Blackberry phone
  • http//www.linkedin.com/in/delumeau
  • delumeau.phv_at_me.com

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.
3
Harmonization in Pharmacovigilance
  • ICSR submission requirements
  • Electronic submission (E2B standards)
  • Aggregate reports submission requirements
  • Coding dictionary
  • Risk Management Plan and Risk mitigation
    requirements

4
Harmonization in Pharmacovigilance ICH 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

5
E2B systems for ICSR management
6
WHO-UMC International Safety Survey
  • Uppsala Monitoring Center appointed by WHO
  • Preferred ICSR transmission standard E2B
  • Alternative old INTIS standard

7
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

8
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

9
Language for domestic ICSR Submission
  • Hong Kong
  • Singapore
  • Malaysia
  • India
  • Pakistan
  • Philippines
  • Indonesia
  • Vietnam
  • Cambodia
  • Thailand
  • Taiwan

ENGLISH and/or LOCAL LANGUAGE ACCEPTABLE
  • China
  • Korea
  • Japan

LOCAL LANGUAGE MADATORY
ENGLISH MANDATORY
10
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

11
Safety submission requirements East Asia
Domestic Solicited Domestic Non Solic. Overseas Solicited Overseas Non Solic. Lingua ? Web Submiss. E2B eSub Aggregate Reports RMP
Japan ??? No Yes ??? ???
Korea ??? Mandatory No ??? not yet
China ?? Mandatory No ?? ??
Hong Kong Eng.?? No No G-PSUR G-RMP
Macao No No
Taiwan Eng.?? Possible No G-PSUR discussions

Expedited Global ICSR format acceptable Expedited Global ICSR format acceptable Expedited Global ICSR format acceptable Expedited Global ICSR format acceptable Unavailable or no requirement specified Unavailable or no requirement specified Unavailable or no requirement specified G-PSUR G-RMP
Expedited Country-specific ICSR format Expedited Country-specific ICSR format Expedited Country-specific ICSR format Expedited Country-specific ICSR format Unavailable or no requirement specified Unavailable or no requirement specified Unavailable or no requirement specified Specific Specific
12
ICSR Reporting requirements Hong Kong
13
ICSR Reporting requirements Korea
14
ICSR Reporting requirements Taiwan
15
ICSR Reporting requirements China
16
ICSR Reporting requirements Japan
17
Safety submission requirements ASEAN
Domestic Solicited Domestic Non Solic. Overseas Solicited Overseas Non Solic. English Web Submis. E2B eSub Aggregate Reports 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 Expedited Global ICSR format acceptable Expedited Global ICSR format acceptable Expedited Global ICSR format acceptable Unavailable or no requirement specified Unavailable or no requirement specified Unavailable or no requirement specified G-PSUR G-RMP
Expedited Country-specific ICSR format Expedited Country-specific ICSR format Expedited Country-specific ICSR format Expedited Country-specific ICSR format Unavailable or no requirement specified Unavailable or no requirement specified Unavailable or no requirement specified Specific Specific
18
ICSR Reporting requirements Indonesia
19
ICSR Reporting requirements Thailand
20
ICSR reporting requirements Philippines
21
ICSR reporting requirements Vietnam
22
ICSR Reporting requirements Singapore
23
ICSR Reporting requirements Malaysia
24
Safety submission requirements South Asia
Domestic Solicited Domestic Non Solic. Overseas Solicited Overseas Non Solic. Lingua ? Web Submiss. E2B eSub Aggregate Reports RMP
India English Hospitals No G-PSUR
Pakistan English No No G-PSUR
Sri Lanka
Maldives
Bangladesh
Nepal
Expedited Global ICSR format acceptable Expedited Global ICSR format acceptable Expedited Global ICSR format acceptable Expedited Global ICSR format acceptable Unavailable or no requirement specified Unavailable or no requirement specified Unavailable or no requirement specified G-PSUR G-RMP
Expedited Country-specific ICSR format Expedited Country-specific ICSR format Expedited Country-specific ICSR format Expedited Country-specific ICSR format Unavailable or no requirement specified Unavailable or no requirement specified Unavailable or no requirement specified Specific Specific
25
ICSR Submission requirements Pakistan
26
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

27
ICSR Submission requirements India
  • New reporting form proposed by the CDSCO

28
ICSR Submission requirements India
  • Categories of clinical trials to be specified in
    the new reporting form

29
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 (???)
  • ICSR submission via National web system is
    mandatory
  • China (??)
  • Korea (???)
  • Thailand (English acceptable)
  • Concern more and more counties will make it
    mandatory

30
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

31
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 WHOs 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

32
Impact of country-specific requirements China
  • 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
    companies
  • and 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

33
Impact of country-specific requirements China
  • 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

34
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

35
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)

36
E2B solutions for 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.

37
E2B solutions for 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

38
Diversity of Safety Systems In Asia News 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 DIADR 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

39
Different viewpoints but 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)

40
Thank you for your attention
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