PMDA and the Ministry of Health, Labour and Welfare of Japan (MHLW) give importance to regulatory dialogue regarding medical products, as well as other relevant matters in view of strengthening the relationship and promoting the cooperation with the National Pharmaceutical Regulatory Agency (NPRA), the regulatory authority for pharmaceuticals and the Medical Device Authority (MDA) , the regulatory authority for medical devices in Malaysia. PMDA co-holds symposia with NPRA regularly and organizes some seminars for Malaysia.
＜Pharmaceutical＞
Symposia
The Malaysia-Japan Symposium is planned and co-hosted by NPRA and PMDA to tighten the mutual relationship and the cooperative framework for regulation of pharmaceutical products and to promote thorough understanding of regulatory systems of the two host countries.
2nd
Date: July 14, 2022
Location: Online
Number of participants: 382
Program [135 KB]
1st
Date: March 10 and 11, 2015
Location: Kuala Lumpur, Malaysia
Number of participants: 150
Program [243 KB]
Seminar
PMDA holds the ATC seminar for NPRA based on their requests.
FY2024
GCP (Good Clinical Practice) Inspection
Date: August 26, 2024
Location: Online
Number of participants: 20
Report
Generic Drugs Review
Date: July 11, 2024
Location: Online
Number of participants: 39
Report
FY2023
First in Human studies of Regenerative Medical Products
Date:July 26, 2023
Location: Online
Number of participants: 23
Report
For other seminars, please click the Seminar Schedule page.
＜Medical device＞
Seminar
PMDA holds the ATC seminar for MDA based on their requests.
FY2021
COVID-19 related In Vitro Diagnostics (IVDs) Review
Date: February 8, 2022
Location: Online
Number of participants: 66
Report
Medical Devices Review (Reprocessed Single-Use Medical Devices (R-SUD))
Date:September 1, 2021
Location: Online
Number of participants: 32
Report