PMDA-ATC Herbal Medicine Review Seminar 2024
The PMDA-ATC Herbal Medicine Review Seminar 2024 was held in Toyama Prefecture from November 12 to 15. This seminar was intended for officials from overseas regulatory agencies involved in reviewing herbal medicine applications and was attended by 15 regulators from Egypt, India, Indonesia, Malaysia, the Philippines, Thailand, and Uzbekistan.
The seminar opened with the remarks by Dr. KONDO Emiko, Senior Executive Director of PMDA, Director of the Asia Training Center, followed by Ms. ISHIDA Miki, 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 Kampo and OTC drugs, the Japanese Pharmacopoeia (JP), and the international harmonization of herbal medicines but also the fundamental concepts and indications of Japanese traditional medicine. On the morning of the second day, each country presented and shared information on the regulations and systems for traditional and herbal medicines. In the afternoon, they visited Alps Pharmaceutical Ind. Co., Ltd., Toyama plant, and they received a lecture on the quality and manufacturing control of raw materials and crude drugs, followed by a tour of the plant. On the morning of the third day, lectures were given on the forefront of herbal medicines in modern medical care and GMP investigations for herbal medicines. In the afternoon, they visited Kracie, Ltd., Takaoka plant, and received a lecture on the quality and manufacturing control of Kampo products, followed by a plant tour. On the fourth day, they visited the Center for Medicinal Plant Resources and looked around the field after a lecture. The lecturers comprised one staff member from the PMDA; three from the Toyama Prefectural Government; one from the National Institute of Health Sciences; two from the University of Toyama; one from Alps Pharmaceutical Ind. Co., Ltd.; one from the Kracie, Ltd.; and one from the Federation of Pharmaceutical Manufacturers’ Associations of Japan. (See the program for details[108KB])
This event was closed with the remark by Dr. KONDO Emiko. As a token of active participation in the seminar, the digital certification of Open Badge was given to the participants.
Photos and participants comments
Comments from the participants:
- During the seminar, we learnt diverse nature of regulatory framework of participating countries with ultimate goal to safeguard the consumers.
- I learn so much about the quality of the herb from the cultivation until becoming product, and the GMP from the expert. I gain so much knowledge about Kampo product.
- Overall, it was comprehensive and well organized.
- The seminar was truly enriching and worthwhile, offering invaluable opportunities to exchange knowledge about the regulation and legal frameworks for herbal products across different countries.
