RA-EWG (Regulations and Approvals Expert Working Group)

Please refer to each link for more information.

About us

RA-EWG Goal, Leader’s Message and Membership

Our Approaches Task A: Good Registration Management

The concept of GRM is to promote both Good Review Practice (GRevP) by the reviewers and Good Submission Practice (GSubP) by the applicants cooperatively.

APAC RA-EWG facilitates implementation of the GRM/GSubP in cooperation with the APEC RHSC and the other stakeholders.

Task A: APAC Position Paper

Objectives of APAC Position Paper is “To provide high level suggestions and proposals to the regulatory authorities from the viewpoint of industry” for supporting promotion of GRevP.

Task B: Convergence of NDA Requirements

The goal is to promote regulatory convergence in Asia by supporting adoption and implementation of the internationally harmonized regulatory guidelines and practices by the regulatory authorities

Training: Under construction

Training information of Good Registration Management will be available.

Publications

Analysis report

Identification and Clarification of the Differences in Regulatory Requirements among Asian Economies on the areas of IND, NDA, Clinical Trials and GMP Evaluation System

Deliverables from APAC annual conference

GSubP Guideline, APAC Position Paper, etc., which were generated through RA-EWG activities on GRM, Task A or Task B.

Events Calender

Key activities by APAC RA-EWG

Links

Ministry Health, Regulatory Authorities or Pharmaceutical Associations related to RA-EWG member economies