It is my pleasure to welcome you to the website of APAC (Asia Partnership Conference of Pharmaceutical Associations). APAC is an industry-driven initiative with thirteen R&D-based pharmaceutical associations joining from eleven economies in Asia that agree to work together to realize the mission; “To expedite the launch of innovative medicines for the peoples in Asia”. Since its establishment in 2012, APAC has focused on activities in the fields of “Drug Discovery Alliances” (DA) and “Regulations and Approvals” (RA), to improve “Access to Innovative Medicines” (ATIM) in Asia.
Through our annual meetings in the past eight years, we have provided unique opportunities for constructive discussions among regulators, academia and industries on timely topics. In the 6th & 7th APAC, for example, we proposed and discussed common Site Master File (SMF) template, Post-approval variation, Conditional Early Approval (CEA) and Drug Discovery Eco-system using natural compounds, in which we have formed a better understanding of ATIM issues and ideas for solutions to those issues.
At the 8th APAC that was held in April 2019, while continuing sessions of ATIM, RA and DA for discussion about Stability Data Requirement for Post-Approval Changes, Good Registration Management, Reliance Pathway for Approval of Innovative Medicines in APAC and Revitalization of Drug Discovery using Natural Products by Open Innovation in Asia, we launched Value-based Healthcare (VBH) session for the first time. As the base for the panel discussion, we introduced the two key concepts of JPMA’s “Policy Recommendation 2019” which are corporate accountability and transparency in drug price calculations, because we believe that it is necessary to consider methods and systems to assess multifaceted values of drugs from both objective and expert perspectives. It was meaningful to share with the APAC participants joining from Asia the recognition about the ongoing environmental change of society and the economy in Japan, and deepen mutual understandings about how we should address the issues regarding the healthcare and social security system.
Further, a new integrated report named "Pharmaceutical Market and Regulatory Environment (PMRE) in Asia" was created and offered to the APAC participants. We are very much proud of the teamwork provided by all the member associations to compile the informative deliverables.
APAC’s mission can only be accomplished with close cooperation with various stakeholders such as government bodies, regulatory agencies and academia. In this regard, we are proud of our collaboration with the APEC (Asia-Pacific Economic Cooperation Conference) Regulatory Harmonization Steering Committee, where APAC’s activities have contributed to their efforts toward regulatory convergence in Asia.
We would also like to have stakeholders’ understanding and continued support to APAC’s activities toward the realization of our common goal “To expedite the launch of innovative medicines for the peoples in Asia”.
Japan Pharmaceutical Manufacturers Association