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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