MISSION

The APEC LSIF GRM CoE is hosted by the Taiwan Food and Drug Administration, Ministry of Health and Welfare (TFDA) with the Regulatory Affairs Professionals Society Taiwan Chapter (RAPS Taiwan Chapter) for promoting regulatory convergence and understanding in the area of Good Registration Management (GRM).

GRM is a concept to promote efficient registration process for medical products by promoting Good Review Practices (GRevP) and Good Submission Practices (GSubP) cooperatively. To promote GRM is to benefit the patients with timely access of medical products which are both efficacious and in good quality. GRevP represents documented best practices for any aspect related to the process, format, content and management of medical product reviews. The goal of GRevP is to strengthen the performance, predictability, and transparency of regulatory agencies through the implementation or enhancement of GRevP. GSubP is an industry practice for any aspect related to the process, format, content, and management of submission for registration of medical products by applicants. The purpose of GSubP is to enhance the quality and efficiency of the medical product registration process by improving the quality of application dossiers, thereby enhancing the reviewing efficiency.

The primary objectives of the GRM CoE are to advance the APEC Roadmap to promote GRM through focused training and to train more trainers for disseminating the concept of GRM in each APEC member economies (Train-the-Trainer model). Since 2016, the annual APEC GRM workshop organized by the APEC LSIF GRM CoE has brought together key stakeholders, including regulatory agencies, academia and industry of APEC economies to discuss the best practices and promote regulatory science of  GRM, GRevP and GSubP.

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COE HOSTING INSTITUTIONS

Taiwan Food and Drug Administration, Ministry of Health and Welfare (TFDA)
Regulatory Affairs Professionals Society RAPS Taiwan Chapter (RAPS)

 

 

GRM ROADMAP & MILESTONES

Concept of GRM Roadmap

Good Registration Management

 

“Regulatory convergence” has been a priority of APEC Life Sciences Innovation Forum (LSIF) for needed patients to have early access to innovative medical products. The Regulatory Harmonization Steering Committee (RHSC) was established in 2009 to set up a strategic framework for regulatory convergence with the objectives of creating synergies, avoiding duplication of efforts, and setting up a roadmap for stepwise implementation. Since 2016, Chinese Taipei and Japan have co-championed the priority work area (PWA) of GRM. The “2020 Roadmap for Good Registration Management" was then endorsed by the RHSC in the same year2016.

GRM is the concept to promote both GRevP by regulators and GSubP by industry cooperatively and thereby enhance the quality and efficiency of the medical product registration process. The implementation of GRM concept and its key elements, GRevP and GSubP, based on the best international practices would be an essential basis for enhancing regulatory convergence among APEC economies.

 

Outline of GRM roadmap

Outline of GRM roadmap

 

Milestones

 

Year Milestone
2011
Good Review Practice (GRevP) was endorsed as a priority work area (PWA) by APEC LSIF-RHSC . Chinese Taipei was endorsed as the champion.
2013
APEC 2020 Roadmap for GRevP on Medical Products was endorsed.
Gap analysis of GRevP is published.
2014
Good Submission Practice (GSubP) was endorsed as a PWA by RHSC.
2014-2015
Good review practices: guidelines for national and regional regulatory authorities was adopted and published by WHO
2016
Good Submission Practice Guideline for Applicants was endorsed by RHSC.
GRevP and GSubP were merged as a PWA entitled Good Registration Management (GRM). A combined roadmap was endorsed by RHSC. Chinese Taipei and Japan were endorsed as the co-champions. RAPS Taiwan Chapter was endorsed as the a Center of Excellence (CoE) for GRM pilot program by RHSC. A CoE Pilot Workshop was held in Taipei in Nov 2016.
RAPS Taiwan Chapter was endorsed as a Center of Excellence (CoE) for GRM pilot program by RHSC. A CoE Pilot Workshop was held in Taipei in Nov 2016.
Mexico COFEPRIS was endorsed as a CoE for GRM pilot program by RHSC.
2017
TFDA in partnership with RAPS Taiwan Chapter was endorsed as a formal APEC GRM CoE by RHSC.
COFEPRIS conducted a CoE pilot workshop in June 2017
TFDA/ RAPS Taiwan Chapter hosted a GRM CoE workshop on 10/31-11/2
2018
TFDA/ RAPS Taiwan Chapter conducted an APEC GRM CoE workshop on 9/26-9/28
Chinese Taipei and Japan prepared GRM Roadmap assessment.
1st GRM Steering Committee teleconference was held.
COFEPRIS decided to terminate their GRM project due to the new administration's decision in December 2018.
2019
Thai FDA was endorsed as a pilot APEC GRM CoE by RHSC.
TFDA/ RAPS Taiwan Chapter conducted a GRM CoE workshop in Taipei on 9/17-9/19.
Thai FDA hosted a GRM CoE workshop in Bangkok on10/26-10/28 .
A KPI survey of Good Submission Practices (GSubP) has been conducted by the industry coalition to individual companies in Nov 2019.
2020
AHC assists the GRM KPI survey in disseminating to APEC economics and will work together with PWA champions in analyzing the survey result.
TFDA/ RAPS Taiwan Chapter canceled to conduct a GRM CoE workshop due to the influence of COVID-19 pandemic.
A GRM Steering Committee Meeting has been convened on July 28th.
GRM KPI Survey has been completed (May 15.-Aub 6, 2020), 19 APEC member economies have responded this survey.

 

GRM STEERING COMMITTEE

2018 GRM Steering Committee Membership List

 

Economy Name Affiliation
Chinese Taipei
Jo-Feng Chi
Churn-Shiouh Gau
Rosa Fu
TFDA
CDE
IRPMA
Japan
Eriko Fukuda
Shinji Hatakeyama
PMDA
JPMA
Singapore Silke Vogel CoRE, Duke-NUS
United States
Paul Brooks
Lawrence Liberti
RAPS
CIRS


2020 GRM Steering Committee Membership List

 

Economy Name Affiliation GRM Steering Committee Role
Chinese Taipei
Chyn-Liang Huang
Mei-Chen Huang

Finny Liu (劉瑞芬)

Taiwan FDA
Taiwan FDA
IRPMA
Co-Chair
Member
Member
Japan
Daisuke Koga
Hirooki Tanabe
Shinji Hatakeyama
PMDA
MHLW
APAC
Co-Chair
Member
Member
Thailand Suchart Chongprasert Thai FDA Member
United States
Lawrence Liberti

Min Chen (李敏珠顧問)

CIRS
Retired from US FDA (2014)
Member
Member


2022 GRM Steering Committee Membership List

 

Economy Name Affiliation GRM Steering Committee Role
Chinese Taipei
Chyn-Liang Huang
Chia-Ping Liu

Finny Liu (劉瑞芬)

Taiwan FDA
Taiwan FDA
IRPMA
Co-Chair
Member
Member
Japan
Junko Sato
Mao Yanagisawa
Shinji Hatakeyama
PMDA
MHLW
APAC
Co-Chair
Member
Member
Thailand Suchart Chongprasert Thai FDA Member
United States
Lawrence Liberti

Min Chen (李敏珠顧問)

Temple University School of Pharmacy
Retired from US FDA (2014)
Member
Member