ICSR Reporting requirements Japan

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The diversity of safety
reporting requirements
and Systems in Asia
2010.05.17 Beijing China
1
Presenter
Jean-Christophe DELUMEAU MD PhD
Head of Pharmacovigilance Asia-Pacific
Bayer Healthcare
Global R&D Center Asia, Beijing
+86 10 6536 0829 office phone
+86 13910420935 Blackberry phone
http://www.linkedin.com/in/delumeau
[email protected]
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.
2
Harmonization in Pharmacovigilance
 ICSR submission requirements
 Electronic submission (E2B standards)
 Aggregate reports submission requirements
 Coding dictionary
 Risk Management Plan and Risk mitigation requirements
3
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
4
E2B systems for ICSR management
5
WHO-UMC International Safety Survey
 Uppsala Monitoring Center appointed by WHO
 Preferred ICSR transmission standard: E2B
 Alternative: old INTIS standard
6
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
7
Diversity of Safety Systems In Asia
 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
 Japan
 India
 China
 Korea
 Thailand
 Taiwan
 Malaysia
 Singapore
 Vietnam
 Indonesia
 Philippines
 Hong Kong
 Cambodia
 Pakistan
8
Language for domestic ICSR Submission
 Indonesia
 Vietnam
 Cambodia
 Thailand
 Taiwan
 China
 Korea
 Japan
ENGLISH and/or
LOCAL
LANGUAGE
ACCEPTABLE
LOCAL
LANGUAGE
MADATORY
 Hong Kong
 Singapore
 Malaysia
 India
 Pakistan
 Philippines
ENGLISH
MANDATORY
9
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
10
Safety submission requirements
East Asia
Domestic Domestic Overseas Overseas
Solicited Non Solic. Solicited Non Solic.
Lingua
語
Web
Submiss.
E2B
eSub
Aggregate
Reports
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
Eng.中文
No
No
G-PSUR
G-RMP
No
No
Possible
No
Hong Kong
Macao
Taiwan
Eng.中文
Expedited: Global ICSR format acceptable
Expedited: Country-specific ICSR format
Unavailable or no requirement
specified
G-PSUR discussions
G-PSUR
G-RMP
Specific
Specific
11
ICSR Reporting requirements Hong Kong
12
ICSR Reporting requirements Korea
13
ICSR Reporting requirements Taiwan
14
ICSR Reporting requirements China
15
ICSR Reporting requirements
Japan
16
Safety submission requirements ASEAN
Domestic
Solicited
Domestic Overseas Overseas English
Web
E2B Aggregate
Non Solic. Solicited Non Solic.
Submis. eSub Reports
Singapore
Standard Possible
No
Brunei
Standard
No
Malaysia
Standard Possible
No
G-PSUR
Accepted Expected
No
G-PSUR
Accepted
No
G-PSUR
Thailand
Web
Web
Indonesia
G-PSUR
Philippines
G-PSUR G-PSUR
Standard
No
G-PSUR
Vietnam
G-PSUR G-PSUR
Accepted
No
G-PSUR
RMP
G-RMP
Cambodia
Laos
Myanmar
Expedited: Global ICSR format acceptable
Expedited: Country-specific ICSR format
Unavailable or no
requirement specified
G-PSUR
G-RMP
Specific
Specific
17
ICSR Reporting requirements Indonesia
18
ICSR Reporting requirements Thailand
19
ICSR reporting requirements Philippines
20
ICSR reporting requirements Vietnam
21
ICSR Reporting requirements Singapore
22
ICSR Reporting requirements
Malaysia
23
Safety submission requirements
South Asia
Domestic
Solicited
Domestic
Non Solic.
Overseas
Solicited
Overseas
Non Solic.
Lingua
語
Web
Submiss.
E2B
eSub
Aggregate
Reports
India
English Hospitals
No
G-PSUR
Pakistan
English
No
G-PSUR
No
RMP
Sri Lanka
Maldives
Bangladesh
Nepal
Expedited: Global ICSR format acceptable
Expedited: Country-specific ICSR format
Unavailable or no
requirement specified
G-PSUR
G-RMP
Specific
Specific
24
ICSR Submission requirements Pakistan
25
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
26
ICSR Submission requirements India
 New reporting form proposed by the CDSCO
27
ICSR Submission requirements India
 Categories of clinical trials to be specified in the new reporting form
28
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
29
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
30
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
31
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
32
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
33
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
34
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)
35
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.
36
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
37
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 DI&ADR center is planning to set a locally designed countryspecific 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
38
Different viewpoints
but sharing similar goals




National Health Authorities




All Pharmacovigilance professionals
Domestic pharmaceutical companies
International Organisation
Multi-National pharmaceutical Companies
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)
39
Thank you for your attention
40
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