Regulations and Approvals Expert Working Group (RA EWG)

In order to realize the APAC's mission, RA EWG produced two deliverables. One is Analysis Report which identifies differences in regulatory requirements on drug development from IND (if applicable), clinical trial, NDA and to manufacturing/ post approval (including GMP evaluation system). The report will be updated annually so as to maintain the information be accurate. And another one is Concept Paper which provides with the fundamental framework in the activities and outlines a strategic multi-year approach. These two documents were finally endorsed by Steering Committee of APAC on 12 April, 2013.

Analysis Report [PDF 3MB]

Concept Paper [PDF 83KB]

Drug Discovery Alliances Expert Working Group (DA EWG)

In order to realize our vision of drug discovery originating from across the Asian region, we will initiate activities that facilitate information exchange, build networks that promote direct discussion, and establish an environment in which it is possible for industry, the public sector, academic institutions, and venture companies in Asia to cooperate. Our short-term goal is to create a platform for open innovation that creates and improves the drug discovery capabilities of each Asian economy.

Concept Paper [PDF 411KB]

Presentation at Steering Committee [PDF 413KB]