APEC LSIF RHSC (Asia Pacific Economic Cooperation, Life Science Innovation Forum, Regulatory Harmonization Steering Committee: hereinafter “APEC”) meeting was held in Santiago, Chile from February 28 to March 1, 2019.

　APEC has so far mainly tackled regulatory convergence in the areas concerning pharmaceuticals, and it is the latest progress to start fully engaging in the area of “Medical Devices” based on the working structure constituted by the regulatory authorities and industry of Japan, the United States and Republic of Korea.

　In this meeting, APEC agreed the full consolidation of the working structure of Medical Devices Area, and endorsed Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) as one of the pilot centers of training (APEC Training Centers of Excellence for Regulatory Science: CoE) in Medical Devices Area based on the accomplishments so far made by PMDA’s Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC).

　PMDA will hold a pilot CoE training seminar on medical devices regulation in November 2019, and based on the result, aim to obtain a formal CoE status in the APEC meeting in the first half of 2020. Through the CoE training seminars, PMDA will promote wider adoption of the international guidelines such ones developed by IMDRF (International Medical Device Regulators Forum) by regulatory authorities, and further contribute to the regulatory convergence in the Asia-Pacific region.

(Supplement 1) About APEC LSIF RHSC

　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.

　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. In Japan, PMDA received the formal CoE endorsement in the areas of “Multi Regional Clinical Trials/GCP-inspection” and “Pharmacovigilance” before this meeting, and has been providing seminars in the two areas in PMDA-ATC. (See the table below.)

(Table) RHSC’s work areas and their champion economies and CoEs (As of March 1, 2019)

Area	Champion Economy (regulatory authority)	CoE
MRCT/GCP inspection	Japan, Thailand	PMDA (Japan) Peking University (China) Duke-NUS (Singapore) MRCT Center of Brigham and Woman’s Hospital and Harvard (the United States)
Pharmacovigilance	Republic of Korea	PMDA (Japan) KIDS (Republic of Korea) Peking University (China) *
Biotherapeutics	Republic of Korea	Northeastern University (the United States) Soul National University (Republic of Korea) * Duke-NUS (Singapore) *
Advanced Therapies	Singapore	Northeastern University (the United States) * Duke-NUS (Singapore) *
Good Registration Management	Chinese Taipei, Japan	RAPS Taiwan Chapter with TFDA TFDA (Thailand) *
Global Supply Chain Integrity	the United States	USP (the United States) University of Tennessee Health Science Center (the United States) Taylor’s University (Malaysia) *
Medical Devices	Japan, the United States, Republic of Korea Sub-champions: Japan Medical Imaging and Radiological Systems Industries Association (JIRA), Advanced Medical Technology Association (AdvaMed)	NIDS (Republic of Korea) * PMDA (Japan) * University of Southern California (the United States) * Northeastern University (the United States) *

CoEs marked “*” are in a pilot phase. Underlined pilot CoEs are endorsed in this meeting.

(Supplement 2) Working Structure of Medical Devices Area

　The working structure of Medical Device Area is as the table above. The champions (regulatory authorities of Japan, the United States and Republic of Korea) sets the overall directions of the area and subject matters of training seminars, and are responsible for governing activities of the sub-champions and CoEs. The sub-champions (JIRA and AdvaMed) propose specific issues for convergence to the champions based on gap-analysis of regulations of member economies, and advice to training programs of CoEs. Each CoE conducts training seminars based the directions of champions and advices from the sub-champions.

　The subject matters of training seminars are designed to promote regulatory convergence for member economies based on the international guidelines such as GHTF and IMDRF guidelines in the following points: 1. Standardization and streamlining of pre-market conformity assessment system, 2. Utilization of the international standards of QMS and reciprocal acceptance of QMS audit reports, and 3. Advancement of Post-market safety vigilance system.