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July 26, 2024
Safety
New
PMDA Risk Communication: Purified pineapple stem juice, etc. posted
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July 17, 2024
Safety
Revisions of PRECAUTIONS: Epoprostenol sodium, etc. posted
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July 16, 2024
Events
USP-MHLW/PMDA Joint Workshop
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July 16, 2024
JP
USP-MHLW/PMDA Joint Workshop - Registration started
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July 11, 2024
RS
Recent Publications by PMDA Staff updated
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July 9, 2024
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.411 posted
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July 9, 2024
Events
Call for PMDA-ATC Herbal Medicine Review Seminar 2024 has been opened
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July 9, 2024
Int
Seminar schedule has been updated
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July 1, 2024
Other
Establishment of PMDA Asia Office - as First Overseas Base - (News Release) (July 1, 2024) [266.84KB]
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July 1, 2024
Review
English Translation of Review Report: Spikevax (bivalent, Original/Omicron BA.4-5) Partial Change Approval
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June 27, 2024
Int
PMDA Updates (June 2024) posted
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June 26, 2024
Review
List of Approved Products (New Drugs): April 2004 to March 2024
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June 21, 2024
Review
GMP compliance inspection updated
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June 20, 2024
Review
English translation of review report: Medtronic Percept PC (Partial Change Approval)
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June 20, 2024
Safety
Notifications Related to Safety Measures (Drugs): ”Amendment of the Instructions for Electronic Package Inserts Regarding Results of Studies Using Medical Information Database” and “Points to Consider for Describing the Results of Studies Using Medical Information Database in Electronic Package Inserts” posted
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June 19, 2024
Review
Information on biosimilars is updated
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June 18, 2024
Review
English Translation of Review Report: Abecma (Partial Change Approval)
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June 7, 2024
Pub cmt
JP Drafts (June 2024) No.2 posted
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June 7, 2024
Pub cmt
JP Drafts (June 2024) No.1 posted
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June 7, 2024
JP
PDG April 2024 Press Release posted
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June 6, 2024
Int
Asian Network Meeting (ANM) posted
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June 6, 2024
Events
Call for PMDA-ATC GMP Inspection Seminar 2024 has been opened
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June 3, 2024
JP
PDG (Pharmacopoeial Discussion Group) Stage 2 Drafts (June 2024) posted
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June 3, 2024
Int
Training material is updated
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May 30, 2024
Review
Pamphlet of Regulatory Science Consultations is posted
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May 21, 2024
Review
List of Approved Products (Medical Devices): April 2004 to September 2023
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May 7, 2024
Safety
PMDA Alert for Proper Use of Drugs: Dependence Associated with Benzodiazepine Receptor Agonists, revised and posted
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May 7, 2024
Review
List of Approved Products: FY2023 (April 2023 to December 2023)
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May 7, 2024
Int
ICMRA COVID-19 Virus Variants Workshop held in February 2024 posted
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April 10, 2024
Safety
Notifications Related to Safety Measures (medical devices): Questions and Answers (Q&A) on MR Safety of Implantable Medical Devices, etc. (Part 2) posted
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April 8, 2024
Review
The information of New Drug Review with Electronic Data updated
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April 1, 2024
Other
The new Purpose established on the 20th anniversary of the PMDA – PMDA will move to a new stage to make everyone’s brighter lives.- (News Release)