ASEAN-Japan Pharmaceuticals Training in Risk Management Plan

Proponent : Indonesian Food and Drug Authority (Indonesian FDA)
Implementing Agency : Organising Committee comprised of Indonesian Food and Drug Authority (Indonesian FDA); Pharmaceuticals and Medical Devices Agency (PMDA), Japan; Faculty of Pharmacy, University of Indonesia


Harmonisation of pharmaceutical regulations plays an increasingly important role in eliminating technical barriers to trade without compromising the quality or safety of the medicines. When country-specific regulations apply, additional testing and examination may be necessary before a product can be approved. This lengthens the review period and increases costs, causing delayed patient access to potentially lifesaving drugs. This has led ASEAN to advance harmonization among ASEAN Member States through the development of regional guidelines in reference to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines.

Risk Management Plans (RMP) is a key document developed by ICH that provides information on a medicine’s safety profile. It will allow regulatory authorities to share safety information more effectively and efficiently. In an effort to ensure the adherence to RMP, training workshop at the regional level is required to provide common understanding among ASEAN Member States.

The project aims to leverage the resources and know-how of Japan and ASEAN on the regulatory harmonisation concerning drug products. It will involve Japanese experts in the areas of drug and medical device product regulation through platforms such as the Asia Training Center for Pharmaceutical and Medical Device Regulatory Affairs (PMDA-ATC) managed by Japan’s local regulator.

What is the project aiming for?

The project endeavors to enhance capacity of ASEAN regulators over the period of two (2) years through the conduct of following activities. They will be comprised of foundational training and symposium in the first year and advanced topics in the second year:

  • Two (2) training workshops for regulatory staff from all ASEAN Member States on RMP; and
  • Two (2) symposiums and two (2) reports to disseminate essential regulatory information on RMP and exchange perspectives among regulators and industries.

It is hoped that the synergy and collaboration between regulators of ASEAN member countries can draft the harmonised regulations and requirements so that a country does not do redundant procedures because it already has the same standards. Thus, ASEAN member countries move and act like one country, one unity in terms of regulations and requirements.

Remarks of Sochart Chongrasert
The Chairperson of ASEAN Consultative Committee
for Standards and Quality- Pharmaceutical 
Product Working Group (ACCSQ PPWG) Meeting
26th Meeting of ACCSQ-PPWG
6-8 November 2018
Jakarta, Indonesia

ASEAN-Japan Pharmaceuticals Training in Risk Management Plan promotes “cooperation on expansion of high quality health services, pharmaceuticals and medical devices” as stipulated in the Revised Implementation Plan of the Vision Statement on ASEAN-Japan Friendship and Cooperation states that ASEAN and Japan. In addition, it is in line with the ASEAN Economic Community (AEC) Blueprint 2025, A.1.10: Work towards facilitative standards and conformance.

As of 28 February 2021

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