Here begins the text.
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