The PMDA held the “PMDA-ATC Quality Control (Herbal Medicine) Webinar 2022” from August 23 to 25. It was designed for officials of overseas regulatory agencies engaged in drug reviews, attended by 25 regulators from Azerbaijan, Bhutan, Botswana, China, Ethiopia, India, Laos, Malaysia, Mexico, Pakistan, Philippines, Saudi Arabia, Sri Lanka, Sudan, Taiwan, Thailand, Tunisia.
Before attending the webinar, participants took the PMDA-ATC E-learning course, “Quality Control (Herbal Medicine)” covering topics: Regulation and Review Process of
Over-the-Counter (OTC) Drugs, Japanese Pharmacopoeia (JP), Non-JP Crude Drug Standards, Approval Standards for OTC Kampo Medicines and Crude Drug Preparations, GMP Inspection by Prefectural Authorities, Efforts of the Center for Medicinal Plant Resources.
The live webinar was opened with remarks by Mr. UZU Shinobu, Senior Executive Director of PMDA and Director of PMDA-ATC. Subsequent lectures were provided by representatives of the Toyama prefectural government, Institute of Natural Medicine of Toyama University, Center for Medicinal Plants Resources (Toyama Prefectural Institute for Pharmaceutical Research), the Federation of Pharmaceutical Manufacturers Association of Japan, National Institute of Health Sciences and PMDA staff.
The webinar comprised lectures and Q&A sessions on Overview of Regulations on Herbal Medicines in Japan, Quality Evaluation of Crude Drugs, Quality Management and Manufacturing Management of Crude Drugs, Overview of JP and Approval Standards for OTC Kampo Medicines and Crude Preparations as well as case studies including group discussions on “GMP Inspection for Herbal Medicines” and “Approval of Herbal Medicines based on the Approval Standards." (See agenda for details).
The webinar was closed with the remarks by Mr. UZU Shinobu. The course completion certificate was handed to the participants virtually by Mr. UZU.
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Comments from the participants:
“ The lecturers are knowledgeable and can well articulate on their assigned topics /expertise. thank you for trying hard to understand our questions.”
“ It was wonderful experience and valuable guidance.”
“ New information regarding quality.”
“ I can knew the experience from your country.”
“ It is good to know that your government spearheads the sustainability in resources of your local herbal medicines.”
” Very clear and I see best practices in your herbal medicine regulation and management.“
“ Interesting case studies as well which made for interesting group discussion.“