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
|Priority Work Areas (PWAs)||Champion Economy|
|MRCT/GCP inspection||Japan, Thailand|
|Pharmacovigilance||Republic of Korea|
|Biotherapeutics||Republic of Korea|
|Good Registration Management||Chinese Taipei, Japan|
|Global Supply Chain Integrity||the United States|
|Medical Device||Japan, the United States, Republic of Korea
Japan Medical Imaging and Radiological Systems Industries Association (JIRA) Advanced Medical Technology Association (AdvaMed)
PMDA was endorsed to become formal CoEs for “MRCT/GCP inspection” PWA and “Pharmacovigilance” PWA by APEC in 2017 and Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) provides the training seminars about these two areas. Also, PMDA was endorsed to become formal CoE in "Medical Device" PWA by APEC in 2020.
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; it was the first endorsement of CoE for academic institution in Japan
Press release that PMDA was endorsed by APEC (Ministry of health Labour and Welfare)