The PMDA and the Ministry of Health, Labour and Welfare of Japan (MHLW) give importance to regulatory dialogue regarding medical products, as well as other relevant matters in view of strengthening the relationship and promoting the cooperation with the Indonesian Food and Drug Authority (Indonesian FDA), the regulatory authority for pharmaceuticals and the Ministry of Health (MoH), the regulatory authority for medical devices in Indonesia. The Indonesian FDA and the MHLW concluded the Memorandum of Cooperation (MOC) in 2021. Based on this MOC, the PMDA organized some seminars for the Indonesian FDA and the Indonesian FDA, the University of Indonesia(UI) and the PMDA co-hosted symposia for ASEAN member states.On the other hand, the PMDA has conducted the one year long-term trainees from the MoH since April 2024.
<Pharmaceuticals>
Memorandum of Cooperation
Indonesia (Indonesian FDA)
Memorandum of Cooperation (August 2021)
Japanese document [438.00KB]
English document [136.69KB]
Symposia
It was co-hosted by the PMDA, the Indonesian FDA and the University of Indonesia that the ASEAN-Japan Risk Management Plan Symposium for regulators in ASEAN Member States (AMS) in 2022 and 2023 (Seminar was described at the next page).
The symposium and the seminar were supported by the Japan - ASEAN Integration Fund (JAIF).
［FY2023］
Date：May 24, 2023
Location： Jakarta (Indonesia) and Online
Number of Participants： In person 271, Online 248
Symposium Report by the University of Indonesia：
https://aseanrmp.ui.ac.id/
［FY2022］
Date：May 23, 2023
Location： Online
Number of Participants： 283
Seminar
It was co-hosted by the PMDA, the Indonesian FDA and the University of Indonesia that the ASEAN - Japan Risk Management Plan Seminar for regulators in ASEAN Member States - (AMS) in 2022 and 2023.
PMDA also held the PMDA-ATC seminar for the Indonesian FDA based on their requests.
［FY2023］
Title：ASEAN-Japan Risk Management Plan Seminar 2023
Date：May 25,26, 2023
Location：Jakarta（Indonesia）
Number of Participants：39
Report
［FY2022］
Title：ASEAN-Japan Risk Management Plan Seminar 2022
Date：May 24,25, 2022
Location： Online
Number of Participants：28
Report
Title： COVID-19 Vaccine Review
Date： October 24, 2022
Location： Jakarta (Indonesia) and Online
Number of Participants：Approx. 80名
Report
Title：CMC Review
Date： March 9, 2023
Location：Online
Number of Participants：122
Report
<Medical Devices>
The Long-term Training Program
The long-term trainees from the MoH
The PMDA has started a one-year long-term training program in the field of medical device regulation under the framework of the “Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs” since April 2024.
The MoH and the PMDA signed a Letter of Intent on Long-term Training Program:
PMDA Updates August 2023 [662.56KB]
The PMDA has started a one-year long-term training program:
PMDA Updates May 2024 [802.47KB]