Introduction
The Pharmaceuticals and Medical Devices Agency (PMDA) will organize the “PMDA-ATC Pharmaceuticals Review Seminar 2026 for PPWG” for reviewers of ASEAN member states. The seminar will be held IN PERSON from October 6 to 9, 2026.
This seminar provides practical training focused on the scientific and regulatory review of new drugs. The seminar will cover Japanese regulatory requirements, key considerations in the new drug evaluation process, and the structure/content of PMDA review reports/Risk Management Plans (RMPs). The training program includes case studies based on products approved by PMDA, and a plant visit to an active pharmaceutical ingredient (API) manufacturing facility,
Key Objectives of this Seminar
- Enhance participants' ability to evaluate quality, non-clinical (toxicology), and clinical data submitted for new drug applications.
- Support capacity building for strengthening the assessment process of ASEAN Joint Assessment (JA) and bilateral reliance schemes.
- Support capacity building for conducting full assessments of new drugs in each authority.
Who should apply
Regulators of ASEAN Member States ONLY (Intermediate or higher level)
- Staff of regulatory authorities who are involved in
or
2) ASEAN Joint Assessment (JA) for over 2 years.
- Participants must have sufficient English proficiency to actively engage in, and benefit from lectures and discussions conducted in English.
- All participants are recommended to view designated material before participating in the seminar.
Dates / Time
October 6 (Tuesday) - 9 (Friday) 2026Program
Please refer to the linked program [76.0KB]
Fee
There is no registration fee to participate in this seminar.
- Detailed information on travel arrangements and hotel reservations will be provided to selected participants. Further information available at: PMDA Frequently Asked Questions (FAQ)
- International travel insurance is not covered by PMDA, but PMDA strongly recommends all participants to purchase a plan.
Seminar Venue
Pharmaceuticals and Medical Devices Agency (PMDA)
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
Contact Us
For more information, please contact:
Secretariat, PMDA Asia Training Center
E-mail: PMDA-ATC[at]pmda.go.jp
Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan
(Note: For security, @ in e-mail addresses are replaced with [at]. Please replace [at] with @ to reach us.)