Pharmaceuticals and Medical Devices Agency (PMDA) recently completed the PMDA-Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC) Regenerative Medicinal Products Review Webinar 2021 for NPRA, Malaysia on March 19, 2021, in collaboration with the National Pharmaceutical Regulatory Agency (NPRA), Malaysia. A total of 53 regulators of NPRA, who are engaged in review, inspection and surveillance of pharmaceuticals including regenerative medicinal products, participated in the webinar.
The webinar covered topics relating to the regulation and review process of regenerative medicinal products, specially focusing on the human somatic cell-processed products and the plasmid vector products, aiming at providing deeper insight into the present challenges in these areas.
In the webinar, the lecturers from PMDA and NPRA shared the information on the regulatory framework for regenerative medicinal products, and the lecturers from PMDA introduced the experience in the review of the human somatic cell-processed products and the plasmid vector products.
The webinar opened with the remarks by Mr. UZU Shinobu, Director of PMDA-ATC in video message and by Dr. Azizah Ab Ghani, Senior Principal Assistant Director, Head of Biologics Section, Centre for Product and Cosmetic Evaluation, NPRA.
At the end of the webinar, Dr. FUJIWARA Yasuhiro, Chief Executive of PMDA awarded the course completion certificate virtually by recorded video, and Dr. Azizah gave the closing remarks.
Comments from the participants:
“Overall regulations in PMDA has provided insights to the process and was very informative.”
“Very useful sharing on somatic cell type and plasmid vector type regenerative medicinal products.”
“The cases were helpful for guidance for evaluation.”
“This webinar is very useful as an insight into the PMDA regenerative medicine authorization regulation and evaluation.”
“The case studies were very effective in enhancing the understanding with regards to dossier requirements and evaluation of regenerative medicines.”
“It was a useful session that allowed us to be familiar with the situations of CGTP regulations in both countries.”
PMDA-ATC Seminars/Webinars are held periodically, with a different theme for each seminar/webinar.
The Seminar/Webinar announcements are posted on this website.
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