Priority Work Areas

Centers of Excellence

Advanced Therapy Products

Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore [CoE]

Northeastern University (NEU), United States [CoE]

United States Pharmacopeia (USP), United States [CoE]

Biotherapeutic Products

Kobe University, Japan [CoE]

Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore [Pilot CoE]

Northeastern University (NEU), United States [CoE]

Global Supply Chain Integrity

Taylor’s University, Malaysia [CoE]

The University of Tennessee Health Science Center (UTHSC), United States [CoE]

United States Pharmacopeia (USP), United States [CoE]

Good Registration Management

TFDA with Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, Chinese Taipei [CoE]

Food and Drug Administration, Thailand (Thai FDA) [CoE]

Medical Devices

Sichuan University (SCU), China [CoE] 

Pharmaceutical and Medical Devices Agency (PMDA), Japan [CoE]

National Institute of Medical Device Safety Information (NIDS), Korea [CoE]

Soonchunhyang University (SCH), Korea [CoE]

Centre of Regulatory Excellence (CoRE), Duke-NUS Medical School, Singapore [Pilot CoE]

Taiwan Food and Drug Administration (TFDA), Chinese Taipei [CoE] 

Northeastern University (NEU), United States [Pilot CoE]

University of Southern California (USC), United States [CoE]

Multi-Regional Clinical Trials & Good Clinical Practice Inspection

Peking University (PKU), China [CoE] 

Pharmaceutical and Medical Devices Agency (PMDA), Japan (with National Cancer Center (NCC), Japan) [CoE]

Korea National Enterprise for Clinical Trials (KoNECT), Korea [CoE]

Centre of Regulatory Excellence, Duke-NUS Medical School, Singapore [CoE]

The MRCT Center of Brigham and Women's Hospital and Harvard (MRCT Center), United States [CoE]

Pharmacovigilance

Peking University (PKU), China [CoE]

Korea Institute of Drug Safety and Risk Management (KIDS), Korea [CoE]

Pharmaceutical and Medical Devices Agency (PMDA), Japan [CoE]