Introduction of APEC-LSIF-RHSC
APEC-LSIF-RHSC is one of the committees under APEC, which is the economic collaboration framework by 21 economies in the Asia-Pacific region, and tasked to promote regulatory convergence of pharmaceuticals and medical devices in the region. Major regulatory authorities, industry organizations and academia participate in RHSC, and Japan and the United States serve as co-Chairs. APEC-LSIF-RHSC sets the priority work areas (PWAs) for regulatory convergence and subjects of training seminars, and designates regulatory authorities and academic institutions which have excellent knowledge and experience in the region as Centers of Excellence (CoEs). CoEs provide training seminars for other regulatory authorities and others, which lead to regulatory convergence.
APEC-LSIF-RHSC Public Website
APEC-LSIF-RHSC’s work areas and their champion economies (As of May 20, 2021)
| Priority Work Areas (PWAs) | Champion Economy |
|---|---|
| MRCT/GCP inspection | Japan, Thailand |
| Pharmacovigilance | Republic of Korea |
| Biotherapeutics | the United States Sub-champion: Biotechnological Innovation Organization (BIO) |
| Advanced Therapies | Singapore, the United States Sub-champion: Biotechnological Innovation Organization (BIO) |
| Good Registration Management | Chinese Taipei, Japan |
| Global Supply Chain Integrity | the United States |
| Medical Device | Japan, the United States, Republic of Korea Sub-champions: Japan Medical Imaging and Radiological Systems Industries Association (JIRA), Advanced Medical Technology Association (AdvaMed) |
Center of Excellences (CoEs) in Japan
PMDA was endorsed to become formal CoEs for “MRCT/GCP inspection” PWA and “Pharmacovigilance” PWA in 2017, and “Medical Device” PWA in 2020 by APEC. Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) provides the training seminars about these three areas. Also, NCC was endorsed to become joint formal CoE with PMDA for " MRCT/GCP inspection" PWA by APEC in 2021.
Furthermore, Kobe University held the workshop for "Biotherapeutics" PWA with support from Ministry of Health, Labour and Welfare and it was endorsed to become formal CoE in 2020; it was the first endorsement of CoE for academic institution in Japan.
Press release that PMDA was endorsed by APEC
- "MRCT/GCP inspection PWA" and "Pharmacovigilance PWA" (Endorsement for becoming formal CoEs) (Vietnam in Feb. 2017) (Only Japanese)
- "Medical Device PWA" (Endorsement for becoming formal CoE) (web meeting June, 2020) (Only Japanese)
- "MRCT/GCP inspection PWA" (Endorsement for becoming joint formal CoE, PMDA and NCC) (27th Apr. 2021)