PMDA-ATC Generic Drugs Review Seminar 2026
The PMDA-ATC Generic Drugs Review Seminar 2026 was held in Toyama Prefecture from July 14 to 17, 2026 (program link [171KB]). The seminar welcomed 25 regulatory officials from 10 countries and regions, namely Chinese Taipei, Egypt, India, Indonesia, Lao PDR, Malaysia, Pakistan, the Philippines, Thailand and Viet Nam, and provided opportunities to enhance their knowledge of generic drug review practices and regulatory frameworks and to exchange experiences.
The seminar opened with welcome remarks from TAMIYA Kenichi, Executive Director of PMDA-ATC, and TAKEUCHI Daisuke, Senior Director, Pharmaceutical Business Promotion Division, Health and Welfare Department, Toyama Prefectural Government. They welcomed the participants to Toyama Prefecture and expressed their hope that the seminar would contribute to strengthening regulatory capacity and international collaboration in the field of generic drugs.
Lectures covered a wide range of topics including an overview of the Japanese pharmaceutical review system, the ICH M13 guideline and Japanese guidelines on bioequivalence (BE) studies, as well as the review of over-the-counter (OTC) drugs and quasi-drugs. At the round table discussion, the participants gave presentations on generic drug review systems and regulations in their respective countries. The program also included a case study on a mock review of generic drugs.
Furthermore, as part of the practical training program, participants visited the Yatsuo Plant of Nitto Medic Co., Ltd., where they learned about the manufacturing process for sterile products, including the ophthalmic solutions. They also visited the Toyama No.1 Site of Yoshindo Holdings Co., Ltd., where they observed manufacturing and quality control practices for oral and topical pharmaceutical products. These visits provided valuable opportunities to gain practical insights into the manufacture and quality assurance of pharmaceutical products.
A total of 11 lecturers and facilitators from PMDA, Nitto Medic Co., Ltd., and Yoshindo Holdings Co., Ltd., as well as staff members of Nitto Medic, Yoshindo Holdings, and the Toyama Prefectural Government contributed to the successful implementation of the Seminar. Upon completion of the program, participants were awarded digital certificates.
Opening ceremony
Lecturers
Participants during a lecture session
Case study discussions
Nitto Medic Co., Ltd. and Yoshindo Holdings Co., Ltd.
Comments from participants:
“The seminar was well-organized and provided a comprehensive overview of generic drug review in Japan. The lectures on BE guidelines, the practical case study, and the manufacturing site tours were particularly useful and well-balanced.”
“It is a really interesting seminar and gives a better understanding about how generic drugs are regulated in Japan and other countries, also the site visit to company gives more information about pharmaceutical companies in Japan. Great experience!”
“I plan to apply the knowledge and evaluation practices learned from the PMDA to improve the efficiency and quality of drug review processes in my agency. Sharing these insights with my colleagues will also help align our local standards with international regulatory practices.”
