Good Registration Management

Good Registration Management (GRM) is a concept to promote efficient registration process for medical products by promoting Good Review Practice (GRevP) and Good Submission Practice (GSubP) cooperatively. The goal of the roadmap is to promote the concept of GRM and thereby enhance mutual trust for regulatory convergence among the APEC member economies by 2020. GRevP guidelines (WHO, 2015) and GSubP guidelines (APEC RHSC, 2016) were developed to provide general and high level guidance on the principles and processes of good review and good submission. Training delivered by Centers of Excellence to further promote GRM and regulatory convergence is underway.

CO-CHAMPIONS

  • Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • Taiwan Food and Drug Administration, Chinese Taipei (TFDA)

The PWA Co-Champions’ contacts can be found here.

CENTERS OF EXCELLENCE

  • TFDA with Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, Chinese Taipei
  • Food and Drug Administration, Thailand (Thai FDA)

The respective Centers of Excellence’s contacts and website links can be found here.

ACTIVITIES

2021

AUG-SEP

APEC CoE Training (Virtual)

TFDA with RAPS Taiwan Chapter, Chinese Taipei

AUG

APEC CoE Training (Virtual)

Food and Drug Administration, Thailand (Thai FDA)

2020

JUN

APEC Center of Excellence established

Food and Drug Administration, Thailand (Thai FDA)

2019

OCT

APEC Pilot CoE Training (Thailand)

Food and Drug Administration, Thailand (Thai FDA)

SEP

APEC CoE Training (Chinese Taipei)

TFDA with RAPS Taiwan Chapter, Chinese Taipei

FEB

APEC Pilot Center of Excellence established

Food and Drug Administration, Thailand (Thai FDA)

2018

SEP

APEC CoE Training (Chinese Taipei)

TFDA with RAPS Taiwan Chapter, Chinese Taipei

2017

OCT

APEC CoE Training (Chinese Taipei)

TFDA with RAPS Taiwan Chapter, Chinese Taipei

JUN

APEC Pilot CoE Training (Mexico)

Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Mexico

FEB

APEC Center of Excellence established

TFDA with RAPS Taiwan Chapter, Chinese Taipei

APEC Pilot Center of Excellence established

Federal Commission for the Protection against Sanitary Risk (COFEPRIS), Mexico

2016

NOV

APEC Pilot CoE Training (Chinese Taipei)

TFDA with RAPS Taiwan Chapter, Chinese Taipei

FEB

APEC Pilot Center of Excellence established

TFDA with RAPS Taiwan Chapter, Chinese Taipei

Establishment of the Good Registration Management Priority Work Area