Task A: Good Registration Management (GRM)

Concept

The concept of Good Registration Management (GRM) is to jointly promote Good Review Practice (GRevP) and Good Submission Practice (GSubP) by reviewers and applicants. Close communications between review authorities and applicants during product registration process is the key element of GRM.

Good Submission Practice (GSubP)

APAC Good Submission Practice (GSubP) guideline is a document about the best practices proposed by RA-EWG under the concept of Good Registration Management. It aims to enhance the quality and efficiency of the drug registration process by improving the quality of submission and management. Promotion of GSubP by the industry has been recognized as important counterpart in facilitating Good Review Practice (GRevP) by the regulatory authorities.

Download:APAC Good Submission Practice (GSubP) Guideline for applicants (PDF)

Good Review Practice (GRevP)

Good Review Practice (GRevP) guidelines for regulatory authorities aim at enhancing quality, transparency, timeliness, and predictability of application review. It emanated from a partnership between the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) and the World Health Organization (WHO).

Download:Good Review Practice: guidelines for national and regional regulatory authorities (PDF)

APAC RA-EWG Position Paper

APAC RA-EWG works to promote Good Review Practice (GRevP) by making proposals in the form of Position paper to regulatory authorities from the viewpoint of industry. These position papers are used for facilitating close communication and collaboration between industry and the regulatory authorities to contribute to improving Good Registration Management (GRM) and eventually lead to regulatory convergence and work sharing of drug review in Asia.

Download:APAC Position Paper (PDF)

Progress report Download: 2016 2017

APAC position paper covers the following 5 topics, which are selected as important area for refining existing drug registration process throughout the APAC region.

TOPIC GOAL
Consultation To establish structured framework to support regulatory consultation
Transparency To facilitate transparency to review policy, standards, draft regulations, guidelines, and new initiative from regulatory authority
Tracking System To facilitate transparency to review process and status
Collaborative training To facilitate collaborative training program and workshop between the regulatory authorities and industry
English review report To facilitate generation of review report in English.
- It will help towards building mutual confidence across the regulatory authorities and may lead to future work sharing in drug review

Good Registration Management (GRM) Training

In Feb. 2016, APAC Good Submission Practice (GSubP) Guideline was endorsed by APEC Regulatory Harmonization Steering Committee (RHSC) and has merged with Good Review Practices (GRevP) to become one of the pilot programs for APEC Training Centers of Excellence for Regulatory Sciences (CoEs). APAC Regulations and Approvals Expert Working Group (RA-EWG) fully support the CoEs by design training materials and send trainers for Good Submission Practice (GSubP).

2016 APEC Good Registration Management Regulatory Science CoE Pilot was held on November 15-17 in Taipei. The training is designed under the “Train the trainer” concept, which means industry and reviewers who attended the CoE pilot as trainees will cascade the training down to each economy.

Details including training videos and materials can be found at 2016 APEC .