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What's New
July 20, 2021Revisions of PRECAUTIONS: Magnesium sulfate hydrate/glucose (preparations indicated for prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) , etc. posted
- July 13, 2021MHLW Pharmaceuticals and Medical Devices Safety Information No.384
- July 6, 2021Profile of Services posted
- July 5, 2021List of Approved Products (New Drugs): FY 2020 (April 2020 – March 2021) and FY 2021 (April 2021 – May 2021)
- July 1, 2021English Translation of Review Report: Mayzent
- June 29, 2021PMDA Updates (June, 2021) posted
- June 29, 2021List of Approved Products (Medical Devices): FY2020 (April 2020 -December 2020)
- June 25, 2021PMDA Risk Communication: Magnesium sulfate hydrate/glucose, etc. posted
- June 22, 2021JP 18th Edition (Japanese version) posted
- June 21, 2021List of Approved Products: FY 2020 (April 2020 - March 2021)
- June 17, 2021Global Pharmaceutical Quality Knowledge Management: Enhancing Regulatory Reliance and Agility
- June 17, 2021Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised 11 June 2021)
- June 17, 2021Joint Statement on transparency and data integrity International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO)
- June 17, 2021China and Japan Regional Joint Public Meeting on ICH
- June 10, 2021Joint MHLW/PMDA-USP Workshop schedule program have been updated
- June 7, 2021JP Drafts (June 2021) No.2 posted
- June 7, 2021JP Drafts (June 2021) No.1 posted
- June 2, 2021Information on "ICH Public Web Conference for ICH E6 Guideline for Good Clinical Practice - Update on Progress" updated
- June 1, 2021Urgent Safety Information (the blue letter) Joyclu, has been posted.
- May 24, 2021Chief Executive’s Statement: Toward the Earlier Marketing of Innovative Medical Devices
- May 20, 2021Notifications and Administrative Notices: Basic principles on Utilization of Registry for Applications; Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications
- May 19, 2021Update the page for RWD WG：MHLW notifications on Registry utilization and data reliability
- May 19, 2021The 5th Subcommittee on Microbiome
- May 12, 2021The 39th Science Board Meeting
- April 27, 2021NCC was endorsed to become joint formal CoE with PMDA for "MRCT/GCP inspection" PWA by APEC-LSIF-RHSC.
- April 20, 2021PDG November 2020 Videoconference Meeting Highlights posted
- April 7, 2021Information on implementation of ICH-Q3D into the Japanese Pharmacopoeia posted
- April 1, 2021PMDA-ATC E-learning videos are now available on YouTube