Multi-Regional Clinical Trials and Good Clinical Practice Inspection

The goals of the Roadmap for MRCTs and GCP Inspection PWA are to facilitate implementation of MRCTs and acceptance of MRCT results for drug review by regulatory authorities in APEC region and to promote best practice of GCP inspection. To reach the goals, CoEs are providing training programs so as to disseminate relevant internationally harmonized guidelines such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A, E2F, E5(R1), E6(R1, R2), E8, E9, E10 and E17.

CHAMPIONS

  • Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan 
  • Food and Drug Administration, Thailand (Thai FDA)

CENTERS OF EXCELLENCE

  • Peking University (PKU), China
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Korea National Enterprise for Clinical Trials (KoNECT), Korea
  • 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

ACTIVITIES

2020

JUN

APEC Center of Excellence established

Korea National Enterprise for Clinical Trials (KoNECT), Korea

JAN

APEC CoE Training (Japan)

Pharmaceutical and Medical Devices Agency (PMDA), Japan

2019

NOV

APEC CoE Training (China)

Peking University (PKU), China

SEP

APEC Pilot CoE Training (Korea)

Korea National Enterprise for Clinical Trials (KoNECT), Korea

JUL

APEC Pilot Center of Excellence established

Korea National Enterprise for Clinical Trials (KoNECT), Korea

FEB

APEC CoE Training (Canada)

The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States

JAN

APEC CoE Training (Japan)

Pharmaceutical and Medical Devices Agency (PMDA), Japan

2018

SEP

APEC CoE Training (China

Peking University (PKU), China

AUG

APEC Center of Excellence established

The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States

APR

APEC Pilot CoE Training (United States)

The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States

JAN

APEC CoE Training (Japan)

Pharmaceutical and Medical Devices Agency (PMDA), Japan

2017

DEC

APEC CoE Training (China)

Peking University (PKU), China

FEB

APEC Centers of Excellence established

Pharmaceutical and Medical Devices Agency (PMDA), Japan

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

Peking University (PKU), China

JAN

APEC Pilot Center of Excellence established

The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT Center), United States

APEC CoE Training (Japan)

Pharmaceutical and Medical Devices Agency (PMDA), Japan

2016

JUL

APEC Pilot CoE Training (China)

Peking University (PKU), China

MAR

APEC Pilot CoE Training (Singapore)

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

2014

MAR

APEC Pilot CoE Training (Singapore)

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