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 areas 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.
|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 Devices||Japan, the United States, Republic of Korea
Japan Medical Imaging and Radiological Systems Industries Association (JIRA) Advanced Medical Technology Association (AdvaMed)
PMDA was endorsed becoming formal CoEs for “MRCT/GCP inspection” and “Pharmacovigilance” by APEC and Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) provides the training seminars about two areas. And PMDA was also endorsed as the pilot CoE in "Medical Devices" by APEC and is aiming to obtain a formal CoE status in the APEC meeting in the first half of 2020.
Press release that PMDA was endorsed by APEC (Ministry of health Labour and Welfare)