The 7th“Asia Partnership Conference of Pharmaceutical Associations (APAC)”:
Our Mission: To expedite the launch of innovative medicines for the peoples in Asia.
Putting our mission into the center of this time theme, the 7th APAC was held on 10th April, 2018 at the Golden Room of Keidanren-Kaikan, with more than 350 participants coming from our member association economies including government regulators and academia.
＜Convention Agreement – Consensuses of each session＞
Regulations and Approvals
Good Registration Management (GRM)
◆RA-EWG will continuously contribute the implementation of the APEC GRM CoE Workshop and the GRM/GSubP trainings in collaboration with GRM CoE.
◆In FY2018, RA-EWG starts the examination of performance indicators for GRM/GSubP to assess the impact of the activities.
Conditional Early Approval (CEA) System
◆In the 7th APAC meeting, we have reached a consensus that CEA is an effective and efficient way to promote early access to highly necessary medicines for patients in Asia, and that multi-regional drug development and entry of medicines to different countries may face challenges without convergence of CEA approaches.
◆RA-EWG will continue exploring the possibility of further convergence of early approval systems in Asia.
Access To Innovative Medicines
Site Master File (SMF)
◆Regulators and Industries have reviewed the SMF template, and reached consensus to use it.
(SMF template will be informed & discussed in PIC/s Committee Meeting in Geneva as regional initiative actions.)
◆In the 7th APAC meeting, we have confirmed each difference for the post-approval variations fields, especially for CMC & stability documents.
◆APAC will seek a possibility of convergence of the framework to facilitate the management of post-approval changes in a predictable and efficient manner.
Drug Discovery Alliances
1.Pillar 5 has made remarkable progress in creation of the cross-border open innovation platform using natural products. APAC DA-EWG commits to advancing Pillar 5* as an effective initiative to realize "Drug Discovery Ecosystem in Asia"
2."Drug Discovery Ecosystem in Asia" is a foundation of productive cross-border open innovation. Establishment of the system will create more synergy among the stakeholders and increase chances of innovation in drug discovery.
3.Networking, communication, information sharing and capacity building are critical to establish "Drug Discovery Ecosystem". APAC DA-EWG will promote them by working on the Pillar activities in collaboration with Asian countries.
*Pillar 5: Natural Products Drug Discovery
The 8th APAC will be held on April 9, 2019 at the Keidanren-Kaikan, Tokyo.
≪Files used in each session≫
Regulation & Approval Session
Theme: Regulatory landscape for “Access to Innovative Medicine” in Asia
Part-1: Further dissemination of GRM
Part-2: “Conditional Early Approval (CEA) Systems in Asia
Part-3: Summary of RA-EWG activities in FY2017
Access To Innovative Medicines Session
Theme: Promoting Efficiency in GMP Review and Post-approval Variations
Part-1: Site Master File (SMF)
Part-2: Post-approval variations
Drug Discovery Alliance Session
Theme: How to Establish Drug Discovery Ecosystem in Asia
Panel Discussion & Summary