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What's New
January 7, 2021MHLW Pharmaceuticals and Medical Devices Safety Information No.379
- January 6, 2021PMDA Updates (December, 2020) posted
- December 25, 2020English Translation of Review Report: Refixia
- December 21, 2020Notification on self-check, posted
- December 21, 2020Revisions of PRECAUTIONS: Lidocaine hydrochloride/adrenaline (excluding preparations for dental use), etc. posted
- December 18, 2020PMDA Risk Communication: Pomalidomide, etc. posted
- December 16, 2020Seminar on GCP Renovation -Recent Work of ICH and Overview of ICH E6(R3)-
- December 15, 2020List of Approved Products (New Drugs): FY 2020 (April 2020 - October 2020)
- December 15, 2020English translation of review summary: NeuCure BNCT Dose Engine, NeuCure BNCT System, and RETISSA Medical
- December 15, 2020List of Approved Products (Medical Devices): FY2020 (April 2020-June 2020)
- December 14, 2020The 7th Thailand-Japan Symposium
- December 14, 2020Report of the PMDA-ATC Japanese Pharmacopoeia Webinar 2020 for Thai FDA
- December 7, 2020Statement on continuation of vaccine trials
- December 1, 2020Statement from Global Medicines Regulators on the Value of Regulatory Reliance
- December 1, 2020PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (December, 2020) posted
- November 24, 2020Chief Executive’s Statement: To Boost Japan-first Medical Product Approvals ~ PMDA Now Looks at Next Steps ~
- November 20, 2020EMA-FDA and PMDA GCP Pilot Collaboration Report posted
- November 20, 2020The Science Board has prepared a report summarizing the issues to be considered in the development of gene therapy products using genome-editing technology.
- November 19, 2020ICMRA AMR campaign is in progress, November 19 to 24, 2020.
- November 18, 2020PMDA Medical Safety Informations: No.23, posted
- November 18, 2020Report of the PMDA-ATC Quality Control (Herbal Medicine) Webinar 2020
- November 17, 2020The 6th Subcommittee on Computer Simulation
- November 16, 2020WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines
- November 16, 2020ICMRA meeting: COVID-19 Real-World Evidence and Observational studies #4
- November 13, 2020Report of the PMDA-ATC & U.S. FDA Pediatric Review Webinar 2020
- November 13, 2020English Translation of Review Report: Nepic
- November 9, 2020PMDA-ATC Pharmacovigilance Webinar 2021
- November 5, 2020The 2nd Subcommittee on Microbiome
- November 4, 2020PMDA-ATC Pharmaceuticals Review Webinar 2020 for Drug Administration of Vietnam
- November 4, 2020The 2nd Vietnam-Japan Symposium
- October 29, 2020PMDA Alert for Proper Use of Drugs: No.13
- October 20, 2020Notifications and Administrative Notices: A new Notification and Administrative Notice on Medical Devices (dated on Nov.17, 2017)
- October 12, 2020PMDA Reveals Principles on Evaluation of COVID-19 Vaccines
- October 12, 2020The 5th Subcommittee on Computer Simulation
- October 6, 2020PMDA to Offer Free Scientific Advice for COVID-19 Vaccines Development
- October 6, 2020PMDA-ATC with National Cancer Center MRCT Webinar 2021
- October 1, 2020Report of the PMDA-ATC Medical Devices Webinar 2020 for Thai FDA
- September 25, 2020PMDA-ATC Pharmaceuticals Review Webinar 2020 for NPRA, Malaysia
- September 25, 2020PMDA-ATC Japanese Pharmacopoeia Webinar 2020 for Thai FDA
- September 23, 2020PMDA-ATC Pharmaceuticals Review Webinar 2020
- September 11, 2020The 37th Science Board Meeting
- September 7, 2020JP Drafts (September 2020) posted
- August 24, 2020PMDA-ATC Medical Devices Webinar 2020
- August 24, 2020The 4th Subcommittee on Computer Simulation
- August 18, 2020The 1st Subcommittee on Microbiome
- 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 22, 2020PMDA-ATC & U.S. FDA Pediatric Review Webinar 2020
- 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 8, 2020The 3rd Subcommittee on Computer Simulation
- July 7, 2020List of Approved Products: FY 2019 (April 2019 - March 2020)
- July 6, 2020PMDA-ATC Quality Control (Herbal Medicine) Webinar 2020
- 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
- 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