![Favorite pages[Japanese page]](/files/000137013.png){kind=small}
](/files/000137010.png){kind=small}
- Home
- What's New
Here begins the text.
What's New
August 22, 2019Revisions of PRECAUTIONS:Apomorphine hydrochloride hydrate etc., posted
- 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 14, 2019List of Approved Products (New Drugs): FY2019 (April - June 2019)
- August 14, 2019English Translation of Review Report: Vyndaqel (Partial Change Approval)
- August 14, 2019English translation of review report: RFA System and Cool-tip RFA System E Series
- August 6, 2019PMDA-ATC Medical Devices Seminar 2019
- August 6, 2019MHLW Pharmaceuticals and Medical Devices Safety Information No.365
- August 5, 2019The PDG 30th Anniversary Symposium - The History and Future Perspective of PDG - Registration started
- July 31, 2019PMDA Updates (July, 2019) posted
- 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 19, 2019PMDA Risk Communication:Ropinirole hydrochloride, etc. posted
- 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
- June 18, 2019List of Approved Products: FY 2018 (April 2018 - March 2019)
- June 13, 2019English Translation of Review Report: JACC
- June 7, 2019Revisions of PRECAUTIONS: Gel-filled Breast Implant posted
- 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