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What's New
December 8, 2023The 10th Thailand-Japan Symposium
- December 7, 2023JP Drafts (December 2023) posted
- December 7, 2023English Translation of Review Report: Omvoh
- December 7, 2023The 4th Subcommittee on Cell and Gene Therapy Products Produced in vivo
- December 6, 2023【Warning】 Please Be Aware of Phishing E-mails Pretending to be from the PMDA (December 6, 2023)
- December 1, 2023PMDA Risk Communication: Ciltacabtagene autoleucel posted
- December 1, 2023PMDA Risk Communication: Acetazolamide, etc. posted
- December 1, 2023PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (December, 2023) posted
- November 29, 2023PMDA Updates (November, 2023) posted
- November 27, 2023List of Approved Products (New Drugs): FY 2023 (April 2023 to August 2023)
- November 24, 2023Revisions of PRECAUTIONS: Nivolumab (genetical recombination) posted
- November 20, 2023PMDA-ATC Pharmacovigilance Webinar 2024
- November 17, 2023The 4th Vietnam-Japan Symposium
- November 13, 2023Recent Publications by PMDA Staffs updated
- November 9, 2023MHLW Pharmaceuticals and Medical Devices Safety Information No.405
- November 7, 2023English Translation of Review Report: Breyanzi (Partial Change Approval)
- November 1, 2023English translation of review report: SUSMED Med CBT-i App for Insomnia
- October 31, 2023PMDA-ATC GMP Inspection Webinar 2024
- October 30, 2023PMDA Medical Safety Informations: Precautions in Handling of Tracheostomy Tubes (No. 2) posted
- October 27, 2023PDG October 2023 Press Release posted
- October 23, 2023Profile of Services posted
- October 17, 2023PMDA-ATC/AMDC Medical Devices Webinar 2023
- October 12, 2023ICMRA statement on the safety of COVID-19 vaccines
- October 12, 2023ICMRA (International Coalition of Medicines Regulatory Authorities) updated
- October 6, 2023PMDA’s Activities Leading to Medical Device Innovation posted
- October 6, 2023The 3rd Subcommittee on Cell and Gene Therapy Products Produced in vivo
- October 5, 2023List of Approved Products: FY2022 (April 2022 to March 2023) and FY2023 (April 2023 to June 2023)
- October 2, 2023FAQs on Electronic Study Data Submission posted
- September 27, 2023List of Approved Products (Medical Devices): FY 2022 (April 2022 to December 2022)
- September 26, 2023GMP Compliance Inspection concerning Drugs and Quasi-drags of Foreign Manufacturers
- September 26, 2023GMP compliance inspection
- September 25, 2023Notifications Related to Safety Measures (Regenerative Medical Products) : Partial Revision of the "Instructions for Electronic Package Inserts of Regenerative Medical Products" and Partial Revision of the "Instructions for Package Inserts of Regenerative Medical Products (Detailed Rules)" posted
- September 25, 2023Quality Assurance Activities
- September 11, 2023The 2nd Subcommittee on Cell and Gene Therapy Products Produced in vivo
- September 7, 2023JP Drafts (September 2023) posted
- August 29, 2023Revisions of PRECAUTIONS (Regenerative Medical Products): Axicabtagene ciloleucel, etc. posted
- August 29, 2023The 1st Subcommittee on Cell and Gene Therapy Products Produced in vivo
- August 28, 2023The 6th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
- August 9, 2023The information of Regulatory Science Consultations updated
- August 4, 2023 ‘Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials’ posted
- August 4, 2023The 46th Science Board Meeting
- July 27, 2023PMDA Alert for Proper Use of Drugs: Appropriate Measures to Be Taken for Pemphigoid Due to Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, posted
- June 30, 2023JP 18th Edition Supplement I (English version) posted
- June 20, 2023PMDA-ATC Pharmaceuticals Review Webinar 2023
- May 26, 2023Cooperation between WHO and PMDA on training for regulatory authorities
- May 17, 2023The 4th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
- May 9, 2023Regenerative Medical Products Information posted
- May 9, 2023Regulations Regarding Living Modified Organisms (Genetically Modified Organisms) posted
- April 11, 2023The 5th Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning