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What's New (FY2020)
March 31, 2021The 38th Science Board Meeting
- March 30, 2021Revisions of PRECAUTIONS (Cellular and Tissue-based Products): Onasemnogene abeparvovec, posted
- March 30, 2021Revisions of PRECAUTIONS: Magnesium sulfate hydrate/glucose, etc. posted
- March 23, 2021MHLW Pharmaceuticals and Medical Devices Safety Information No.381
- March 23, 2021Chief Executive’s Statement: Utilization of Real World Data - PMDA’s approaches -
- March 12, 2021The 4th Subcommittee on Microbiome
- March 5, 2021JP Drafts (March 2021) posted
- February 18, 2021Notification on self-check, posted
- February 18, 2021PMDA Risk Communication (Medical devices Risk Information of ongoing evaluation) :Drug-eluting coronary stent, etc. posted
- February 16, 2021Chief Executive’s Statement: Special Approval for Emergency on First COVID-19 Vaccine in Japan
- February 4, 2021Seminar on GCP Renovation -Recent Work of ICH and Overview of ICH E6(R3)-
- January 27, 2021The 3rd Subcommittee on Microbiome
- January 26, 2021The 7th Subcommittee on Computer Simulation
- January 19, 2021ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness
- 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
- 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 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 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 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 6, 2020PMDA-ATC Quality Control (Herbal Medicine) Webinar 2020
- 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 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