About APEC CoE

The APEC Regulatory Harmonization Steering Committee (RHSC) has established linkages with other harmonization/convergence initiatives, training institutions and key players in order to avoid duplication of effort, promote complementary action and make maximum use of resources. As a part of regulatory harmonization activities, the RHSC has initiated the establishment of Center of Excellence (CoE).

The CoE training is to benefit all parties that are engaged in the healthcare field by continuously providing quality training, and the following is the areas of pilot/formal training for APEC CoE:

• Advanced Therapies Products
• Biotherapeutics Products
• Global Supply Chain Integrity
• Good Registration Management
• Medical Device
• Multi-Regional Clinical Trials - Good Clinical Practices Inspection
• Pharmacovigilance

CoE Institution

Formal CoE Institutions

Priority Work Areas (PWA)	Champion(s)	Centers of Excellence (CoE)	Economy
Advanced Therapies Products	-   Health Sciences Authority (HAS), Singapore -   US Food & Drug Administration (US FDA), United States -   Biotechnology Innovation Organization	Centre of Regulatory Excellence (CoRE), Duke-NUS Medical school	Singapore
		Northeastern University (NEU)	United States
		U.S. Pharmacopeia (USP)	United States
Biotherapeutics Products	-   US Food & Drug Administration (US FDA), United States -   Biotechnology Innovation Organization (BIO)	Centre of Regulatory Excellence (CoRE), Duke-NUS Medical school	Singapore
		Northeastern University (NEU)	United States
		Kobe University	Japan
Global Supply Chain Integrity	-   US Food & Drug Administration (US FDA), United States	U.S. Pharmacopeia (USP)	United States
		The University of Tennessee Health Science Center (UTHSC)	United States
		Taylor’s University	Malaysia
Good Registration Management	-   Taiwan Food & Drug Administration (TFDA), Chinese Taipei -   Ministy of Health, Labour and Welfare (MHLW), Japan -   Pharmaceuticals and Medical Devices Agency (PMDA), Japan	Food and Drug Administration, Thailand (Thai FDA)	Thailand
		TFDA with Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter	Chinese Taipei
Medical Device	-   Ministy of Health, Labour and Welfare (MHLW), Japan -   Pharmaceuticals and Medical Devices Agency (PMDA), Japan -   Ministy of Food and Drug Safety (MFDS), Korea -   US Food & Drug Administration (US FDA), United States -   Japan Medical Imaging and Radiological Systems Industries Association (JIRA), Japan -   Advanced Medical Technology Association (AdvaMed), United States	National Institute of Medical Device Safety Information (NIDS)	Korea
		Soonchunhyang University (SCH)	Korea
		Pharmaceticals and Medical Devices Agency (PMDA)	Japan
		Northeastern University (NEU)	United States
		University of Southern California (USC)	United States
		Taiwan Food & Drug Administration (TFDA)	Chinese Taipei
		Sichuan University (SCU)	China
		Centre of Regulatory Excellence (CoRE), Duke-NUS Medical school	Singapore
Multi-Regional Clinical Trials & Good Clinical Practice Inspection	-   Ministy of Health, Labour and Welfare (MHLW), Japan -   Pharmaceuticals and Medical Devices Agency (PMDA), Japan -   Food & Drug Administration, Thailand (Thai FDA)	Peking University (PKU)	China
		Pharmaceticals and Medical Devices Agency (PMDA)	Japan
		Centre of Regulatory Excellence (CoRE), Duke-NUS Medical school	Singapore
		The MRCT Center of Brigham and Women's Hospital and Harvard (MRCT Center)	United States
		Korea National Enterprise for Clinical Trials (KoNECT)	Korea
Pharmacovigilance	-   Ministy of Food and Drug Safety (MFDS), Korea	Korea Institute of Drug Safety and Risk Management (KIDS)	Korea
		Pharmaceticals and Medical Devices Agency (PMDA)	Japan
		Peking University (PKU)	China

Pilot CoE Institutions

Priority Work Areas (PWA)	Champion(s)	Centers of Excellence (CoE)	Economy
Biotherapeutics Products	-   US Food & Drug Administration (US FDA), United States -   Biotechnology Innovation Organization (BIO)	Centre of Regulatory Excellence (CoRE), Duke-NUS Medical school	Singapore
Medical Device	-   Ministy of Health, Labour and Welfare (MHLW), Japan -   Pharmaceuticals and Medical Devices Agency (PMDA), Japan -   Ministy of Food and Drug Safety (MFDS), Korea -   US Food & Drug Administration (US FDA), United States -   Japan Medical Imaging and Radiological Systems Industries Association (JIRA), Japan -   Advanced Medical Technology Association (AdvaMed), United States	Northeastern University (NEU)	United States
		Centre of Regulatory Excellence (CoRE), Duke-NUS Medical school	Singapore