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.

2013 2014 2015 2016 2017 2018 2019* 2020 2021 2022

*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

11th APAC (April, 2022)

APAC RA-EWG Concept Paper 2022

APAC RA-EWG Position Paper 2022

Official Replies from NRAs in response to our APAC letter

2020Aug_Official Reply from Taiwan FDA

Survey tool and Progress feedback table in response to our APAC Thank-you letter The Survey tool (3:excel file) was sent out to all APAC member associations on August 24th 2021 except OPPI to obtain inputs on progresses in the emphasize areas in APAC Thank-you letter, and responses were received from 11member associations in Malaysia, Thailand, Taiwan, Hong Kong, Indonesia, Philippines, Singapore, Vietnam, South Korea, and Japan. Such survey responses have been summarized into Simplified Progress feedback Table (4: pdf file)

10th APAC (April, 2021)

Progress Report 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.

APAC letter related to COVID-19 & APAC thanks letter related to COVID-19

9th APAC (April, 2020)

Progress Report 2020

8th APAC (April, 2019)

Progress Report 2019

7th APAC (April, 2018)

Interim Report 2018

6th APAC (April, 2017)

Progress Report 2017

5th APAC (April, 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.

APEC_RHSC Endorsed GRM Roadmap

APEC_RHSC Endorsed GSubP Guideline

This document provides progress of APAC member associations’ activities based on Task A: APAC Position Paper.

Progress Report 2016

4th APAC (April, 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

APAC GSubP guideline is developed to improve the quality of submission dossier and its management.

APAC Position Paper

APAC position paper is intended to further improve the transparency, predictability and timeliness of drug review by facilitating communication with the reviewers.

3rd APAC (April, 2014)

In order to realize the APAC's mission, RA-EWG produced two deliverables focusing on the new drug application (NDA) stage.

APAC GRegiP Policy Document& Appendix

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.

Convergence of NDA Requirements Proposal Document& Fact Sheet

The proposal document on convergence of NDA Requirements describes the common issues and proposed approaches to improve the regulatory requirements for NDA.

2nd APAC (April, 2013)

In order to realize the APAC's mission, RA-EWG produced two deliverables, Analysis Report (refer to above) and Concept Paper.

Concept Paper

Concept Paper provides with the fundamental framework in the activities and outlines a strategic multi-year approach.