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What's New
August 13, 2020English Translation of Review Report: Relumina
- August 7, 2020PMDA-ATC Medical Devices Webinar 2020 for Thai FDA
- August 4, 2020ICMRA meeting: COVID-19 Real-World Evidence and Observational studies #3
- August 3, 2020ICMRA COVID-19 Treatments and Clinical Trials Workshop #2
- July 31, 2020PMDA Risk Communication: Relugolix, etc. posted
- July 29, 2020PMDA Updates (July, 2020) posted
- July 29, 2020PMDA Medical Safety Informations Posted
- July 22, 2020PMDA-ATC & U.S. FDA Pediatric Review Webinar 2020
- July 20, 2020Revisions of PRECAUTIONS:Iodixanol, etc. posted
- July 14, 2020MHLW Pharmaceuticals and Medical Devices Safety Information No.374
- July 10, 2020PMDA Alert for Proper Use of Medical Devices (for patients): For patients who use a ventilator, etc. at home and their families or other caregivers, posted
- July 10, 2020List of Approved Products (Medical Devices): FY2019 (April 2019 to December 2019)
- July 8, 2020The 3rd Subcommittee on Computer Simulation
- July 7, 2020List of Approved Products: FY 2019 (April 2019 - March 2020)
- July 7, 2020List of Approved Products (New Drugs): FY 2020 (April 2020 - May 2020)
- July 6, 2020PMDA-ATC Quality Control (Herbal Medicine) Webinar 2020
- July 3, 2020Notifications and Administrative Notices: 3 guidelines (Exposure-Response Analysis of Drugs, Population Pharmacokinetic and Pharmacodynamic Analysis, and Quality and Safety of Gene Therapy Products)
- June 29, 2020PMDA-ATC Seminar schedule has been updated
- June 25, 2020PMDA was endorsed to be a Center of Excellence (CoE) of Medical Device PWA, APEC-LSIF-RHSC.
- June 23, 2020The 36th Meeting of the Science Board
- June 19, 2020ICMRA statement about confidence in vaccine safety and effectiveness (for healthcare professionals)
- June 19, 2020ICMRA statement about confidence in vaccines (for the general public)
- June 15, 2020Training Materials posted
- June 5, 2020JP Drafts (June 2020) posted
- June 4, 2020For Your Access to Japanese Clinical Trial/Clinical Research Information
- June 1, 2020PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (June, 2020) posted
- May 21, 2020English translation of review summary: Espline SARS-CoV-2
- May 20, 2020ICMRA statement on COVID-19
- May 14, 2020JP17 Updated Errata, JP17-1 Errata, and JP17-2 Errata Posted
- May 13, 2020First Approval of Antigen Test for COVID-19
- May 12, 2020Global regulatory workshop on COVID-19 Real-World Evidence and Observational studies
- May 8, 2020Special Approval for Emergency on Remdesivir for COVID-19
- April 21, 2020Four IVDs Approvals for COVID-19 and Response to the Increased Ventilator Demand
- April 20, 2020Global regulatory workshop on COVID-19 therapeutic development
- April 10, 2020PMDA Takes Further Steps to Speed up Clinical Development of COVID-19 Products
- April 1, 2020Global regulatory workshop on COVID-19 vaccine development