Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) Quality Control (Herbal Medicine) Webinar 2020 on September 9 - 11, 2020 with Toyama prefecture. This webinar was designed for pharmaceuticals reviewers from overseas regulatory authorities. Total of 30 regulators from 15 countries/regions (Australia, Azerbaijan, Bahrain, Brazil, China, Germany, Malaysia, Maldives, Philippines, Singapore, Taiwan, Tanzania, Thailand, Uganda and Vietnam) joined the webinar.
In the webinar, recorded lectures by PMDA staff, representatives from Toyama prefectureral goverment, Institute of Natural Medicine of the University of Toayama, National Institute of Health Sciences, and the Federation of Pharmaceutical Manufacturers‘ Associations of Japan (FPMAJ) were provided in advance as preliminary training materials, which then were followed by live Q&A sessions. The lectures covered the overview of regulations on Herbal Medicines in Japan, quality evaluation of crude drugs (herbal medicine), evaluation process and GMP inspection by prefectural authorities, 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, quality management and manufacturing management of crude drugs and herbal medicines.
The webinar live session opened with remarks by Mr. UZU Shinobu, Director of PMDA-ATC and Ms. AOYAGI Yumiko, Director, Pharmaceutical Policy Division, Health and Welfare Department of Toyama Prefecture.
On the last day, the program included a virtual site tour of the Center for Medicinal Plant Resources in Toyama Prefecture (Toyama Prefectural Institute for Pharmaceutical Research) on cultivation and processing of medicinal platns, and a manufacturing facility of herbal medicine in Toyama on the process of Kampo manufacturing followed by Q&A sessions.
Comments from participants:
<Recorded Lectures and Q&A sessions>
For the session on Overview of Regulation on Herbal Medicines in Japan:
“Thank you for the sharing, it’s very helpful to know the regulations on Herbal Medicines in Japan.”
For the session on Quality Evaluation of Crude Drugs (Herbal Medicine):
“The factors may affect the quality of crude drug are demonstrated well in this section and I learned how to apply the bio-assay to determine the efficacy of crude drug in this section as well.”
For the session on Evaluation Process and GMP Inspection by Prefectural Authorities:
“Roles between prefectural and MHLW are explained clearly in details, types of drugs being approved by the prefectural are also explained in details.”
For the session on Regulation and Review Process of OTC Drugs:“All the questions were answered and explained clearly.”
For the session on Japanese Pharmacopoeia (JP), Japanese Standard for Non- Pharmacopoeial Crude Drugs (Non-JP Crude Drug Standards):
“In this section, the Q and A section is really interesting. Thank you for demonstrating how you set up the acceptance criteria of specification for crude drugs.”
For the session on Approval Standards for Over-the-Counter Kampo Medicines and Crude Drug Preparations
“Interesting topic on using approval standards to regulate products.”
For the session on Quality Management and Manufacturing Management of Crude Drugs and Herbal Medicines:
” Questions were answered clearly”
< Virtual site tour>
For the session on Center for Medicinal Plant Resources
“I love this section! Through this section, I can totally understand how the research center or farmers treat their raw material.”
For the session on Manufacturing site
“I really appreciate the amount of effort in doing the video presentation. I've never been to a crude drug manufacturing site so the video presentation really helped me visualize the manufacturing processes involved. I hope I get to visit the actual plant someday. I am very thankful for PMDA and Toyama for conducting this webinar.”
“The staff is good at dealing with all situations we have during the seminar. Thank you.”
“The webinar was very informative. This is very helpful especially if one has not yet visited an actual manufacturing plant, even though we only got to visit it through the video presentation. I very much appreciate the efforts of PMDA to conduct this webinar amidst the pandemic.”
“The email communication between the participants and the organizers was great. The videos of the research institute on both manufacturing and cultivation of herbal medicines was amazing. The prerecorded videos were very good to learn from. The Q&A needed more attention and details. It may also help sharing more content on the review and QC of herbal medicines.”
PMDA-ATC Seminars are held periodically, with a different theme for each seminar.
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