PMDA-ATC Herbal Medicine Review Seminar 2025
The PMDA-ATC Herbal Medicine Review Seminar 2025 was held in Toyama Prefecture from November 18 to 21. This seminar was intended for officials from overseas regulatory agencies involved in reviewing herbal medicine applications and was attended by 15 regulators from Bhutan, Brunei, Egypt, Indonesia, Laos, Malaysia, Pakistan, the Philippines, Singapore and Thailand.
The seminar opened with remarks by Dr. KONDO Emiko, Senior Executive Director of PMDA, Director of the Asia Training Center, followed by Mr. TAKEUCHI Daisuke, Director, Pharmaceutical Business Promotion Division, Health and Welfare Department of Toyama Prefectural Government.
On the first day, lectures were given on not only the overview of regulations on herbal medicines in Japan, regulation and review process of OTC drugs including Kampo, but also the Japanese Pharmacopoeia (JP) and the international harmonization of herbal medicines. Each participating country also presented and shared information on their regulations and systems for traditional and herbal medicines.
On the morning of the second day, lectures were given on GMP investigations for herbal medicines. In the afternoon, they visited Alps Pharmaceutical Ind. Co., Ltd., Toyama plant, where they attended a lecture on the quality and manufacturing control of raw materials and crude drugs, then toured the plant.
On the morning of the third day, they visited Toyama University and received a lecture on traditional medicines in health science followed by a museum of materia medica tour. They also listened to a lecture on the fundamental concepts and indications of Japanese traditional medicine and the forefront of herbal medicines in modern medical care. In the afternoon, they visited a historical wholesale establishment of herbal medicine with tour guides.
On the fourth day, they visited the Center for Medicinal Plant Resources and toured the field after a lecture.
The lecturers comprised one PMDA specialist, three from the Toyama Prefectural Government; another from the National Institute of Health Sciences; three from the University of Toyama; yet another from Alps Pharmaceutical.
(See the program for details[186KB])
This event was closed with remarks by Dr. KONDO. A digital certificate, Open Badge was awarded to the participants.
Photos and participants comments
Comments from the participants:
- This seminar was very good and provided a lot of new knowledge, especially regarding Kampo Medicine.
- It was a great opportunity to learn about Japan's Regulatory system of herbal medicines and delightful to see contributions from academic and research institutions and also the local pharma industry.
- Site visit to Alps Pharmaceutical is an eye opener.
- I plan to apply the insights gained from the seminar to enhance my current work processes and contribute to more efficient and informed decision-making.
