RA-EWG (Regulations and Approvals Expert Working Group)
Please refer to each link for more information.
RA-EWG Goal, Leader’s Message and Membership
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.
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.
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 information of Good Registration Management will be available.
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.
Key activities by APAC RA-EWG
Ministry Health, Regulatory Authorities or Pharmaceutical Associations related to RA-EWG member economies