Harv Martens ICH M2 JPMA Extedo, Inc.
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Drug Information Association
• ACTD in ASEAN countries • Singapore
– Supports both CTD and ACTD (ASEAN CTD)
• Korea accepts CTD as of March 2009 • Taiwan and others (ASEAN) accept ACTD (Taiwan will accept eCTD soon) – Varying degrees of electronic/paper accepted
• Japan - eCTD
– One of the 3 ICH Regions – Fully supports the ICH M2 Standard • But lifecycle is different… • And module 1 is quite different than other regions 3
ASEAN = Association of Southeast Asian Nations
10 Member Countries Member Countries Indonesia, Malaysia, Philippines, Singapore and pp , g p Thailand (1967) Brunei Darussalam (1984) Vietnam (1995) Lao PDR and Myanmar y (1997) Cambodia (1999)
• As of 2006, ASEAN region has a 2006 population of about 560 million • Total area of 4.5 million square kilometers • Combined gross domestic product almost US$ 1,100 billion 1 100 • Total trade of about US$ 1,400 billion Abida Syed M Haq - Ministry of Health, Malaysia
• ASEAN Consultative Committee for Standards and Quality-Pharmaceutical Product Working Group (ACCSQ PPWG) • The Pharmaceutical Product Working Group (PPWG) was formed in 1999 • The three principle aims are to – create a t t transparent regulatory process t l t – standardize regulation requirements – remove the need for duplicate studies to meet various regulation requirements, th b allowing d l ti i t thereby ll i drug companies more time and resources that can be used towards research and development of new drugs Abida Syed M Haq - Ministry of Health, Malaysia
• On April 10, 2009, the Association of Southeast Asian Nations (ASEAN) E N i Economic Mi i i Ministers signed the i d h ASEAN Sectoral Mutual Recognition Arrangement (MRA) for Good Manufacturing Practice (GMP). • When implemented, GMP certification and inspection reports received in one ASEAN member nation (in accordance with the MRA) will be accepted in all ASEAN countries without requiring additional testing. ti ith t ii dditi l t ti • The MRA also calls for increased harmonization of standards and reduced non-tariff barriers. ASEAN member nations h b ti have until 2011 t f ll i l til to fully implement th t the MRA terms.
Abida Syed M Haq - Ministry of Health, Malaysia
ASEAN Common Technical Requirements (ACTR)
– A set of Written Materials intended to guide applicants to prepare application dossiers in a way that is consistent with the expectations of all ASEAN D Drug R Regulatory A th iti l t Authorities • Can be found on the Singapore HSA web site:
– ASEAN Guideline on Submission of Manufacturing Process Validation Data for Drug Registration – ASEAN Guidelines for Validation of Analytical Procedures – ASEAN Guideline on Stability Study of Drug Product – ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies – ASEAN Guideline on Process Validation Q&A
ACTD - Implementation
• Implementation ASEAN Harmonized Product
– Trial period Sep 03 onwards Sep.03 – Full implementation • for new...