INTRODUCTION

Effective and safe drugs are essential to maintaining and improving public health, and it is the responsibility of the world’s regulators to ensure swift access. Therefore, global harmonisation of technical regulatory requirements for drug product approvals and cooperation among regulatory authorities is essential to realise more efficient product reviews and streamlined exchange of critical safety information.

The ASEAN Economic Community (AEC) Blueprint 2025 emphasises regulatory harmonisation. The Revised Implementation Plan of the Vision Statement on ASEAN-Japan Friendship and Cooperation states that ASEAN and Japan will cooperate in drug and medical device product regulation through platforms like the Asia Training Center for Pharmaceutical and Medical Device Regulatory Affairs (PMDA-ATC) managed by Japan’s local regulator. The ASEAN Pharmaceutical Product Working Group (PPWG) is advancing harmonisation among member states by developing regional guidelines and acknowledging ICH guidelines1 by the Member States.

Corresponding training programming is crucial to help ensure the smooth application of harmonised guidelines. Accordingly, PPWG has listed the types of training most needed based on input from the Member States. The primary goal of this training is to leverage the resources and know-how of ASEAN and Japan to meet these urgent needs. ASEAN-Japan Pharmaceuticals Training in Risk Management Plan（RMP）is a collaboration program conducted by the Indonesian FDA, Pharmaceuticals and Medical Devices Agency (PMDA, Japan), and Universitas Indonesia (UI) with the support of the Japan-ASEAN Integration Fund (JAIF). This project aims to advance regulatory convergence activities concerning drug products among the ASEAN Member States.  The program consists of a seminar geared toward regulatory staffs of ASEAN Member states and a symposium for disseminating essential regulatory information to the industry and academia and exchanging perspectives among regulators, industries, and academia.

By ensuring that the ASEAN Member States are equipped with current knowledge and best practices, drug development and regulatory operations will be well-suited to proceed smoothly and efficiently, helping to ensure swift access to effective and safe drugs. In this 2022, The Indonesian FDA, Pharmaceuticals and Medical Devices Agency (PMDA, Japan) and Universitas Indonesia (UI) by the support of Japan-ASEAN Integration Fund (JAIF) conduct a collaboration programme which is called ASEAN-Japan Pharmaceuticals Training in Risk Management Plan. This project aims to advance regulatory harmonisation activities concerning drug products among the ASEAN Member States.

ASEAN-Japan Risk Management Plan (RMP) Symposium 2023

The ASEAN Risk Management Plan (RMP) Symposium 2023 aims to share the latest information on RMP and its target participants are regulatory authority officials who are engaged in pharmaceutical products review or pharmacovigilance activities in ASEAN Member States (AMS). This Symposium will be held offline at Ayana Midplaza Hotel Jakarta on 24^th May, 2023 in collaboration with Indonesian FDA, Pharmaceuticals and Medical Devices Agency (PMDA, Japan) and University of Indonesia (UI), in support of the Government of Japan through the Japan-ASEAN Integration Fund (JAIF).

ASEAN-Japan Risk Management Plan (RMP) Seminar 2023

The ASEAN Risk Management Plan (RMP) Seminar 2023 aims to share the latest information on RMP and its target participants are regulatory authority officials who are engaged in pharmaceutical products review or pharmacovigilance activities in ASEAN Member States (AMS). This seminar is held at Ayana Midplaza Hotel Jakarta on 25th and 26th May, 2023 following the “ASEAN Risk Management Plan (RMP) Symposium 2023” on 24th May in collaboration with Indonesian FDA, Pharmaceuticals and Medical Devices Agency (PMDA, Japan) and University of Indonesia (UI), in support of the Government of Japan through the Japan-ASEAN Integration Fund (JAIF).