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Report of the PMDA-ATC Quality Control (Herbal Medicine) Webinar 2021

PMDA-ATC Quality Control (Herbal Medicine) Webinar 2021

From June 22 to 24, PMDA held a webinar entitled “PMDA-ATC Quality Control (Herbal Medicine) Webinar 2021“.  This webinar was designed for officials of overseas regulatory agencies engaged in drug reviews, and attended by 31 regulators from Azerbaijan, Brazil, India, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Taiwan, Thailand, Uganda, Vietnam and Zimbabwe.
Before attending the webinar, participants took the PMDA-ATC E-learning course, “Quality Control (Herbal Medcine)“ covering the following: Regulation and Review Process of OTC Drugs; Japanese Pharmacopoeia (JP), Japanese Standards for Non-Pharmacopoeial Crude Drugs (Non-JP Crude Drug Standards); Approval Standards for Over-the-Counter Kampo Medicines and Crude Drug Preparations; and Evaluation process and GMP inspection by prefectural authorities.
The webinar comprised of lectures on Overview of regulations on Herbal Medicines in Japan, Quality Evaluation of Crude Drugs (Herbal Medicine) and Quality Management and Manufacturing Management of Crude Drugs and Herbal Medicines, and Overview of JP and Approval Standards for Over-the-Counter Kampo Medicines and Crude Preparations, in addition to two virtual site tours via video recordings: 1) Efforts of the Center for Medicinal Plant Resources (Toyama Prefectural Institute for Pharmaceutical Research) on cultivation and processing of medicinal platns, and 2) Overview of the manufacturer on storage of crude drugs’ raw materials. 
On Days 2 and 3, case study sessions, including group discussions on the topics “GMP Inspection for Herbal Medicines“, and “Approval of Herbal Medicines based on the Approval Standards“, were held. These case studies were conducted as the first trial this year.
This seminar is also one of the activities of the PMDA Hokuriku Branch in Toyama Prefecture. The lectures and case studies were carried out by representatives from Toyama prefectureral goverment, Institute of Natural Medicine of Toayama University, National Institute of Health Sciences, and the Federation of Pharmaceutical Manufacturers‘ Associations of Japan (FPMAJ) and PMDA staff.

< Program > see the attachement.


Photos and Comments


Comments from the participants: 

"Very useful webinar, excellent with e-learning and live session. There are sharing knowledge with country introduction. Thank you very much."

"It was excellently managed webinar given all the learning as required in herbal medicines and crude drugs which would be of great help to implement it."

"I know better about Japan requirements now."

"It was very informative to get the knowledge of manufacturing and quality management system including GMP adopted for crude drugs and herbal medicines."

"It’s a comprehensive video and it explained step by step of crude drug processing."

"Great session of Case study, giving an insight on how to review an OTC product. Wishes to learn more in the future."