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The diversity of safety reporting requirements and Systems in Asia

This presentation discusses the diversity of safety reporting requirements and systems in Asia, including electronic submission standards, coding dictionaries, risk management plans, and country-specific submission requirements.

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The diversity of safety reporting requirements and Systems in Asia

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  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 R&D Center Asia, Beijing +86 10 6536 0829 office phone +86 13910420935 Blackberry phone http://www.linkedin.com/in/delumeau delumeau.phv@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 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

  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 Indonesia Vietnam Cambodia Thailand Taiwan • Hong Kong • Singapore • Malaysia • India • Pakistan • Philippines 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 requirementsEast Asia

  12. ICSR Reporting requirements Hong Kong

  13. ICSR Reporting requirements Korea

  14. ICSR Reporting requirements Taiwan

  15. ICSR Reporting requirementsChina

  16. ICSR Reporting requirementsJapan

  17. Safety submission requirements ASEAN

  18. ICSR Reporting requirements Indonesia

  19. ICSR Reporting requirements Thailand

  20. ICSR reporting requirements Philippines

  21. ICSR reporting requirementsVietnam

  22. ICSR Reporting requirements Singapore

  23. ICSR Reporting requirements Malaysia

  24. Safety submission requirementsSouth Asia

  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 (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

  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 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

  32. 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 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 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

  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 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.

  37. 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

  38. 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

  39. 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)

  40. Thank you for your attention

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