The ASEAN-Japan Risk Management Plan (RMP) Symposium and Seminar 2022 was held from Monday (May 23, 2022) to Wednesday (May 25, 2022) , a collaboration between the University of Indonesia (UI), the Indonesian Food and Drug Administration (BPOM RI), and the Pharmaceuticals and Medical Devices Agency (PMDA) Japan . The symposium, funded by the Japan-ASEAN Integration Fund (JAIF) and supported by the ASEAN Secretariat (ASEC), aims to enhance drug regulatory harmonization efforts among ASEAN Member States (AMS). Effective and safe drugs are essential for maintaining and improving public health, and it is the responsibility of regulators worldwide to monitor them. Therefore, global harmonization of drug approval techniques and requirements, as well as bilateral and multilateral cooperation between regulators, is essential for efficient review processes and the exchange of safety information.
In this event, the Faculty of Pharmacy, University of Indonesia was entrusted as the implementing agency together with BPOM RI and PMDA Japan. The Dean of FFUI, Prof. Dr. Arry Yanuar, M.Sc., deeply appreciated and expressed his deepest gratitude for the trust given by BPOM RI, PMDA Japan, and JAIF to FFUI in organizing this activity at the ASEAN regional level. Dr. Rani Sauriasari, M.Med.Sci., apt as UI Executive Member for this activity, who is also the Manager of Cooperation, Ventures, and Alumni Relations of FFUI said that this activity is useful for AMS to share important and up-to-date regulatory information regarding RMP with regulators, industry and academics, as well as exchange perspectives between them. The activity will be held twice, namely in May 2022 and 2023.
The RMP Symposium began at 1:13.00 PM WIB (Western Indonesian Time) and was held online. The symposium was divided into three sessions, each ending with a question-and-answer session. Session 3 discussed pharmacovigilance activities in Japan, session 2 discussed the current status of RMP and the perspectives of regulators in Indonesia, and session 3 discussed the role of labeling in minimizing risk.
The following day, Tuesday-Wednesday, May 24-25, 2022, the ASEAN-Japan Risk Management Plan (RMP) Seminar 2022 was held . This seminar had the same focus as the symposium, namely providing the latest information regarding the RMP as an official regulation. The RMP seminar was intended for regulatory staff from ASEAN Member States. The symposium and seminar speakers included experts from PMDA Japan, the Japan Pharmaceutical Manufacturers Association (JPMA), and the Indonesian Food and Drug Authority (BPOM RI).
The overall focus of this project is to advance the harmonization of pharmaceutical regulations regarding medicinal products. When country-specific regulations apply, additional testing and inspections may be required before a product can be approved. This lengthens review periods and increases costs, even delaying patient access to potentially life-saving medicines. Therefore, harmonization of pharmaceutical regulations plays a crucial role in removing technical barriers to drug distribution without compromising quality or safety.
Effective and safe medicines are crucial for improving public health, making it the responsibility of global regulators to ensure prompt and appropriate access. Therefore, global harmonization of technical regulatory requirements for drug product approval and cooperation among regulatory authorities are essential for efficient product review and exchange of safety information. The RMP is a breakthrough developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to provide information on drug safety profiles.
