Depok, May 26th 2023. The Faculty of Pharmacy, Universitas Indonesia (FFUI) collaborated with the Republic of Indonesia Food and Drug Supervisory Agency (BPOM RI) and the Pharmaceuticals and Medical Devices Agency (PMDA) Japan to hold the “ASEAN–Japan Risk Management Plan (RMP) Symposium and Seminar 2023”, on 24th–26th of May 2023, at the Ayana Midplaza Grand Ballroom, Jakarta. This activity funded by the Government of Japan through the Japan–ASEAN Integration Fund (JAIF) and supported by the ASEAN Secretariat (ASEC) aims to enhance efforts to harmonize drug regulations among ASEAN Member States (AMS).
In her opening remarks, UI Secretary, dr. Agustin Kusumayati, M.Sc., Ph.D., said that the world community was very affected by the Covid-19 pandemic for about three years, both in the economic and social fields. When the pandemic first hit, Indonesia did not yet have an adequate level of resilience to a pandemic, especially in the health sector, because it had not yet increased its capacity and ability to manufacture vaccines, medicines, and even protective attributes such as masks. This condition occurred because Indonesia still has to import the materials needed to produce medical devices.
“Universitas Indonesia is fully committed to making contributions that have a big impact on people’s welfare. Therefore, with this activity, we hope that opportunities for cooperation and collaboration with experts and practitioners in the pharmaceutical and health fields from all over the world can be opened. Hopefully, this activity can inspire all researchers, experts and practitioners who are present to create new technologies that are useful in the production of medicines that are safe and of good quality,” said dr. Augustine.
Dean of the Faculty of Pharmacy Universitas Indonesia, Prof. Dr. apt. Arry Yanuar, M.Si., said that this was the second time that FFUI was trusted as the implementing agency together with BPOM RI and PMDA Japan. After previously being held online, this year the symposium was held in a hybrid manner, and was attended by more than 500 face-to-face and online participants. “In this activity, there were 40 regulation participants from 10 ASEAN member countries who attended the seminar for two days, namely on 25th-26th of May 2023. Seminar participants came from Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam,” said Prof. Arry.
Meanwhile, the Ambassador of Mission of Japan to ASEAN, Masahiko Kiya, expressed his appreciation to UI, BPOM RI, and PMDA Japan for organizing this symposium and thanked all the speakers who had participated. According to him, this event is a good opportunity for parties from ASEAN and Asia to take part in efforts to advance world health.
According to Masahiko, with the Covid-19 pandemic, the people of ASEAN and the world have finally realized that a global health system needs to be built to save human lives. As stated by President Jokowi at the G7 meeting in Hiroshima, global health is an important agenda that needs attention, apart from issues of food, energy and climate. The meeting discussed how to strengthen the global health architecture as an effort to deal with future pandemics.
The entire project between ASEAN and Japan will focus on advancing global harmonization activities on pharmaceutical regulations related to medicinal products. When country-specific regulations apply, additional tests and inspections may be required before the product can be approved. This lengthens the review period and increases costs, even causing delays in patient access to drugs. Therefore, the harmonization of pharmaceutical regulations plays an important role in eliminating technical barriers in drug distribution without reducing the quality or safety of drugs.
Effective and safe medicines are needed to improve public health, so it is the responsibility of world regulators to ensure fast and appropriate access. Therefore, global harmonization of technical regulatory requirements for drug product approval and cooperation between regulatory authorities is essential for efficient product review and exchange of safety information.
With this joint effort, Deputy Chairperson of BPOM RI, Dra. apt. Togi Junice Hutadjulu, MHA, is optimistic that the symposium participants from ASEAN member countries will benefit from the latest information from experts and experiences shared in this symposium. “We encourage all participants to create lively interactions from useful discussions,” said Dra. Togi.
