Publications by APAC RA-EWG
Analysis report
Analysis Report identifies differences in regulatory requirements on drug development from IND (if applicable), clinical trial, NDA and to manufacturing/ post approval (including GMP evaluation system). The report will be updated annually so as to maintain the information be accurate.
＊From 2019, market report has been added to analysis report, which has become PMRE (Pharmaceutical Market & Regulatory Environment in Asia) report. PMRE page is HERE
Good Registration Management
RA-EWG has been advocating the concept of good registration management, under which execution of both Good Submission Practices (GSubP) and Good Review Practices (GRevP) by the applicants and the reviewers, respectively, will enhance the performance of both submission and review, leading to efficient and quick drug registration/approval. The latest GRM/GSubP information is as follows.
GSubP guideline is developed to improve the quality of submission dossier and its management.
GSubP Trainer Manual is developed to help Certified GSubP Trainers to organize and manage effective GSubP training program for applicants in their own economy or organization(s).
2024
2023
2022
2020Aug_Official Reply from Taiwan FDA
2021
APAC sent National Regulatory Authorities in Asia two letters which appreciate their regulatory agility during COVID-19 and mention there are four important best practices surrounding regulatory agility that we can work through collectively for areas in need.
2020
2019
2018
2017
2016
Good Registration Management roadmap and Good Submission Practices guideline were endorsed by APEC Regulatory Harmonization Steering Committee (RHSC) in February and April, 2016, respectively.
This document provides progress of APAC member associations’ activities based on Task A: APAC Position Paper.
Please see the Good Registration Management section for the latest GRM/GSubP information.
2015
RA-EWG has been advocating the concept of good registration management, under which execution of both Good Submission Practices (GSubP) and Good Review Practices (GRevP) by the applicants and the reviewers, respectively, will enhance the performance of both submission and review, leading to efficient and quick drug registration/approval. As the industry initiative and proposals, the team prepared the APAC GSubP guideline and APAC position paper documents.
APAC GSubP guideline is developed to improve the quality of submission dossier and its management.
APAC position paper is intended to further improve the transparency, predictability and timeliness of drug review by facilitating communication with the reviewers.
Please see the Good Registration Management section for the latest GRM/GSubP information.
2014
In order to realize the APAC's mission, RA-EWG produced two deliverables focusing on the new drug application (NDA) stage.
The policy document on good registration practice, which can be applied to the APAC regions, contains seven proposals which would make both submission and review of the NDA better.
The proposal document on convergence of NDA Requirements describes the common issues and proposed approaches to improve the regulatory requirements for NDA.
2013
In order to realize the APAC's mission, RA-EWG produced two deliverables, Analysis Report (refer to above) and Concept Paper.
Concept Paper provides with the fundamental framework in the activities and outlines a strategic multi-year approach.