The third Asia Partnership Conference of Pharmaceutical Associations (APAC) was held on 10-11 April at the Imperial Hotel. Out of 13 IFPMA members in Asia, this conference was attended by 12 pharmaceutical associations from China (RDPAC), Hong Kong (HKAPI), India (OPPI), Indonesia (IPMG), Malaysia (PhAMA), Philippines (PHAP), Singapore (SAPI), Korea (KPMA and KRPIA), Taiwan (IRPMA), Thailand (PReMA) and Japan (JPMA). In addition, observers from IFPMA, PhRMA, EFPIA, Interpharma, government officials from Indonesia, Korea, Malaysia, Myanmar, Taiwan, Thailand, Vietnam, and Japan (Cabinet Secretariat, METI, MHLW, MOFA and PMDA) were also there to participate in the conference, bringing the total number of participants to over 300 altogether.

The Third APAC Program [PDF 172KB]

Regulations and Approvals Expert Working Group (RA EWG)

In order to realize the APAC's mission, RA EWG produced two deliverables focusing on the new drug application (NDA) stage and got endorsement from the Steering Committee at the above conference. One is the policy document on good registration practice which can be applied to the APAC regions. It contains seven proposals which would make both submission and review of the NDA better. Another document describes the common issues and proposed approaches to improve the regulatory requirements for NDA. These documents were developed to enhance or promote the dialogue with the review authorities for the regulatory convergence in the APAC regions. In addition, the team also updates the Analysis Report which summarizes the key regulatory information in each APAC country.

APAC GRegiP Policy Document [PDF 236KB]

APAC GRegiP Policy Document (Appendix) [PDF 142KB]

Convergence of NDA Requirements Proposal Document [PDF 264KB]

Fact Sheet [PDF 128KB]

Analysis report 2014 [PDF 2.1MB]

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 for APACs Drug DA EWG [PDF762KB]