The Faculty of Pharmacy, University of Indonesia (FFUI), in collaboration with the Indonesian Food and Drug Monitoring Agency (BPOM RI) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, held the “ASEAN–Japan Risk Management Plan (RMP) Symposium and Seminar 2023” on May 24–26, 2023, at the Grand Ballroom of Ayana Midplaza, Jakarta. Funded by the Government of Japan through the Japan–ASEAN Integration Fund (JAIF) and supported by the ASEAN Secretariat (ASEC), this event aims to enhance efforts to harmonize drug regulations among ASEAN Member States (AMS).
In her opening remarks, the University Secretary, Dr. Agustin Kusumayati, M.Sc., Ph.D., stated that the global community has been severely impacted by the Covid-19 pandemic for approximately three years, both economically and socially. When the pandemic struck, Indonesia lacked adequate resilience, particularly in the health sector, as it had not yet increased its capacity and capability to produce vaccines, medicines, or even protective equipment such as masks. This situation arose because Indonesia still had to import the materials needed to produce medical devices.
"The University of Indonesia is fully committed to making significant contributions to the well-being of society. Therefore, with this event, we hope to open up opportunities for collaboration and cooperation with experts and practitioners in the fields of pharmacy and healthcare from around the world. We hope this event will inspire all researchers, experts, and practitioners in attendance to create new technologies that are beneficial in the production of safe and high-quality medicines," said Dr. Agustin.
The Dean of FFUI, Prof. Dr. apt. Arry Yanuar, M.Sc., stated that this is the second time that FFUI has been trusted as an implementing agency with the Indonesian Food and Drug Authority (BPOM RI) and the Japanese Food and Drug Authority (PMDA). Previously held online, this year's symposium was held in a hybrid format , and was attended by more than 500 participants, both face-to-face and online. "In this activity, there were 40 regulatory participants from 10 ASEAN member countries who attended the two-day seminar, namely on May 25-26, 2023. Seminar participants came from Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam," said Prof. Arry.
Meanwhile, Japan's Ambassador of Mission to ASEAN , Masahiko Kiya, expressed his appreciation to the University of Indonesia (UI), the Indonesian Food and Drug Authority (BPOM RI), and the Japanese Food and Drug Authority (PMDA) for organizing the symposium and thanked all the participating speakers. He stated that this event was a good opportunity for ASEAN and Asia to play a role in advancing global health.
Ambassador of Mission of Japan to ASEAN , Masahiko Kiya
According to Masahiko, the COVID-19 pandemic has finally made ASEAN and global communities realize the need to build a global health system to save lives. As President Jokowi stated at the G7 meeting in Hiroshima, global health is a crucial agenda item, alongside food, energy, and climate issues. The meeting discussed how to strengthen the global health architecture in an effort to address future pandemics.
This overall project between ASEAN and Japan will focus on advancing global harmonization of pharmaceutical regulations related to 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 medicines. Therefore, harmonization of pharmaceutical regulations plays a crucial role in eliminating technical barriers to drug distribution without compromising quality or safety.
Effective and safe medicines are essential for improving public health, so it is the responsibility of global regulators to ensure prompt and appropriate access. Therefore, global harmonization of technical regulatory requirements for drug product approval and cooperation between regulatory authorities are essential for efficient product review and exchange of safety information.
With this joint effort, the Deputy Chairperson of the Indonesian Food and Drug Authority (BPOM RI), Dra. apt. Togi Junice Hutadjulu, MHA, is optimistic that symposium participants from ASEAN member countries will benefit from the latest information and experiences shared by the experts. "We encourage all participants to create lively interactions through fruitful discussions," said Dra. Togi.
