Welcome to APAC RA-EWG website!

Contents of RA-EWG website are summarized here. Please refer to each link for more information.

About usLINK

RA-EWG Goal, Leader's Message and Membership

Goal and Approach of RA-EWG

Our Approaches Task A: Good Registration ManagementLINK

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

Task A: APAC Position PaperLINK

Objectives of APAC Position Paper to support promotion of GRevP
To provide high level suggestions and proposals to the regulatory authorities from the viewpoint of industry.

Task B: Convergence of NDA RequirementsLINK

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 constructionLINK

Training information of Good Registration Management will be available.

PublicationsLINK

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 Good Registration Management Position Paper, etc., related to RA-EWG activities on GRM, Task A or Task B

Events CalenderLINK

Key activities by APAC RA-EWG

LinksLINK

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