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What's New
October 17, 2019English Translation of Review Report: Soliris (Partial Change Approval)
- October 17, 2019Report of the PDG 30th Anniversary Symposium (Held on October 3, 2019)
- October 16, 2019The 34th Meeting of the Science Board
- October 16, 2019The 33th Meeting of the Science Board
- October 16, 2019The 32th Meeting of the Science Board
- October 11, 2019List of Approved Products (New Drugs): FY2019 (April - August)
- October 10, 2019Revisions of PRECAUTIONS (Medical Devices): Drug-eluting coronary stent, etc. posted
- October 9, 2019PMDA-ATC Pharmacovigilance Seminar 2020
- October 4, 2019PMDA Updates (September, 2019) posted
- October 4, 2019PMDA Risk Communication:Vonoprazan fumarate, etc. posted
- October 4, 2019JP Drafts (September 30, 2019) posted
- October 3, 2019Report of the PMDA-ATC & WHO Pharmaceuticals Review Seminar 2019
- October 1, 2019PMDA-ATC Multi-Regional Clinical Trials Seminar 2020
- October 1, 2019English Translation of Review Report: JACE (Partial Change Approval) and Kymriah
- October 1, 2019The PDG 30th Anniversary Symposium - The History and Future Perspective of PDG - Registration form was closed
- September 30, 2019PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (September, 2019) posted
- September 24, 2019English translation of review report: Absorb GT1 Bioresorbable Vascular Scaffold System
- September 24, 2019Revisions of PRECAUTIONS:Baricitinib, etc. posted
- September 18, 2019Report of the PMDA-ATC & U.S. FDA Pediatric Review Seminar 2019
- September 17, 2019MHLW Pharmaceuticals and Medical Devices Safety Information No.366
- September 6, 2019JP Drafts (September 2, 2019) posted
- September 4, 2019PMDA-ATC Quality Control (Herbal Medicine) Seminar 2019
- September 3, 2019The 1st Vietnam-Japan Symposium
- August 16, 2019Notifications and Administrative Notices: PFSB/MDRMPED Notification No. 1121-33, No. 1125-6, No. 0219-1, and 2 PFSB/MDRMPED Administrative Notices
- August 6, 2019PMDA-ATC Medical Devices Seminar 2019
- July 31, 2019"PMDA Medical Safety Information No.58" Posted
- July 24, 2019The 3rd Subcommittee on AMR
- July 23, 2019Briefing materials of "Symposium for the draft revision on the ICH E8 “General Considerations for Clinical Trials”: Update on the ICH and Overview of the ICH E8(R1) Draft Guideline" now available.
- July 22, 2019List of Approved Products (New & Improved Medical Devices): FY2018 (April 2018 - March 2019)
- July 9, 2019Dr. Yasuhiro Fujiwara, Chief Executive of PMDA, elected Vice Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA) (News Release)
- July 1, 2019PMDA-ATC GMP Inspection Seminar 2019
- July 1, 2019PMDA-ATC GMP Inspection Seminar 2019
- June 18, 2019List of Approved Products: FY 2018 (April 2018 - March 2019)
- June 7, 2019JP Drafts (June, 2019) posted
- June 3, 2019The 4th Subcommittee on Genome Editing
- May 31, 2019Patient Centricity Working Group, Projects Across Multi-Offices in PMDA
- May 20, 2019Urgent Safety Information (the blue letter) abemaciclib, case reports added
- April 25, 2019FAQs on Electronic Study Data Submission (Excerpt)
- April 25, 2019PDG March 2019 Videoconference Press Release posted
- April 5, 2019Report of the PMDA-ATC MRCT Seminar 2019
- April 3, 2019The 6th Thailand-Japan Symposium