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What's New（International Activities）

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What's New（International Activities）

November 29, 2023 PMDA Updates (November, 2023) posted
November 1, 2023 HBD East 2023 Think Tank Meeting
November 1, 2023 Training materials (PMDA-ATC learning video) have been updated.
October 17, 2023 Seminar Schedule
October 12, 2023 ICMRA statement on the safety of COVID-19 vaccines
October 12, 2023 ICMRA (International Coalition of Medicines Regulatory Authorities) updated
May 26, 2023 Cooperation between WHO and PMDA on training for regulatory authorities
October 21, 2022 A Regulatory Pharmaceutical Quality Knowledge Management System (PQ KMS) to Enhance the Availability of Quality Medicines
September 12, 2022 PMDA-ATC digital book is now available.
May 27, 2022 Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 17 May 2022)
December 28, 2021 ICMRA Statement on Need for Continued Focus on COVID-19 Therapeutics
November 18, 2021 ICMRA AMR campaign is in progress, November 18 to 24, 2021.
June 17, 2021 Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility
June 17, 2021 Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021)
June 17, 2021 Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)
April 27, 2021 NCC was endorsed to become joint formal CoE with PMDA for "MRCT/GCP inspection" PWA by APEC-LSIF-RHSC.
January 19, 2021 ICMRA statement for healthcare professionals: How COVID-19 vaccines will be regulated for safety and effectiveness
December 7, 2020 Statement on continuation of vaccine trials
December 1, 2020 Statement from Global Medicines Regulators on the Value of Regulatory Reliance
November 20, 2020 EMA-FDA and PMDA GCP Pilot Collaboration Report posted
November 16, 2020 WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines
November 16, 2020 ICMRA meeting: COVID-19 Real-World Evidence and Observational studies #4
October 12, 2020 PMDA Reveals Principles on Evaluation of COVID-19 Vaccines
October 6, 2020 PMDA to Offer Free Scientific Advice for COVID-19 Vaccines Development
August 4, 2020 ICMRA meeting: COVID-19 Real-World Evidence and Observational studies #3
August 3, 2020 ICMRA COVID-19 Treatments and Clinical Trials Workshop #2
June 19, 2020 ICMRA statement about confidence in vaccine safety and effectiveness (for healthcare professionals)
June 19, 2020 ICMRA statement about confidence in vaccines (for the general public)
June 4, 2020 For Your Access to Japanese Clinical Trial/Clinical Research Information
May 20, 2020 ICMRA statement on COVID-19
May 13, 2020 First Approval of Antigen Test for COVID-19
May 12, 2020 Global regulatory workshop on COVID-19 Real-World Evidence and Observational studies
May 8, 2020 Special Approval for Emergency on Remdesivir for COVID-19
April 21, 2020 Four IVDs Approvals for COVID-19 and Response to the Increased Ventilator Demand
April 20, 2020 Global regulatory workshop on COVID-19 therapeutic development
April 10, 2020 PMDA Takes Further Steps to Speed up Clinical Development of COVID-19 Products
April 1, 2020 Global regulatory workshop on COVID-19 vaccine development
March 31, 2020 PMDA pledge to tackle COVID-19 Pandemic
October 31, 2019 HBD East 2019 Think Tank Meeting
November 16, 2017 Third tripartite meeting held between EMA, FDA and PMDA towards enhancing development for Antibacterial Agents posted
October 5, 2017 HBD East 2017 Think Tank Meeting
February 10, 2016 ICMRA's Zika Virus Disease Press Release
June 26, 2015 PMDA International Strategic Plan 2015 announced

Pmda - Pharmaceuticals and Medical Devices Agency

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