PMDA-ATC Quality Control (Herbal Medicine) Seminar 2023
The PMDA held the “PMDA-ATC Quality Control (Herbal Medicine) Seminar 2023” from August 22 to 24 in Toyama. This training seminar was intended for officials from overseas regulatory agencies involved in drug reviews, attended by 13 regulators from Bangladesh, China, Indonesia, Malaysia, the Philippines, Saudi Arabia, Thailand and Vietnam.
The seminar was opened with remarks by Dr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC, followed by Ms. Ishida Miki, Director of Pharmaceutical Business Promotion Division, Health and Welfare Department of Toyama Prefectural Government.
The participants learned Overview of regulations on Herbal Medicines in Japan, Quality Evaluation of Crude Drugs (Herbal Medicine), Regulation and Review Process of Kampo and OTC Drugs, Japanese Pharmacopoeia (JP) and Non-JP Crude Drugs Standards, Drug review and GMP inspections conducted by the Prefectural Government, Approval Standards for OTC Kampo and Crude Drugs, and Quality Control and Manufactural Management of Crude Drugs and Kampo. These lectures were provided by the experts of Health and Welfare Department of Toyama prefectural government, Institute of Natural Medicine of Toyama University, National Institute of Health Sciences, Center for Medicinal Plants Resources (Toyama Prefectural Institute for Pharmaceutical Research), the Federation of Pharmaceutical Manufacturers Association of Japan and the PMDA. Besides these lectures, the training program included on-site tours to visit Alps Pharmaceutical Ind.Co.,Ltd. where the participants learned manufacturing process of herbal medicine preparations and their quality control, and the Center for Medicinal Plant Resources where the participants learned cultivation and processing of medicinal plants. (See the program for details)
While this seminar was held in-person after 3 years interval due to COVID-19 pandemic, the participants actively joined discussons and Q&A sessions so that they understood the Japanese kampo and crude drug regulation and approval process in Japan.
This event was closed with the remark by Ms. ENDO Ayumi, Office Director of Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs. As a token of active participation in the seminar, the digital certification of Open Badge were given to all the participants.
Photos and participant comments
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Comments from the participants:
- The material was very good and I could discuss and share experiences with participants about herbal medicine regulation in each country. The secretariat was also good at organizing the seminar and all the participants actively contributed to the seminar.
- Transferring learned knowledge and skills to my colleagues. Improving current technical guidelines and creating new ones related to subjects that are not covered by the current ones in my country.
- The best presentation with clear information convey to the participants. Through the presentation, we are able to understand the application of approval standards for crude drug and OTC Kampo in Japan.
- It is a great opportunity to learn about the regulations and quality evaluation of herbal products and Kampo medicine in Japan.
- It is a nice exposure to the actual manufacturing process.
- The Center for research and training of Herbal Plant is very important to ensure the standardized quality of medicinal plants. This center can be a role model in building similar research and training centers in my country.
