What's new
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April 1, 2026
Int
New
New PMDA-ATC Learning Video content has been released on the Pmda Channel
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March 31, 2026
Review
New
Principles on Development of Combination Ophthalmic Solutions for Glaucoma (Early Consideration),Considerations for Pre-specifying the Change Categories for Manufacturing Process Parameters Identified as Established Conditions for Drug Products (Chemical Products) (Early Consideration) posted
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March 27, 2026
Safety
New
PMDA Risk Communications: Infliximab (genetical recombination) etc. posted
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March 27, 2026
Review
New
Document-based Inspection to CTD M3(Quality studies)/M4(Non-clinical studies other than GLP studies) data page created
-
March 25, 2026
Review
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
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March 25, 2026
Review
The information of New Drug Review with Electronic Data updated
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March 23, 2026
Other
Recent Publications by PMDA Staff updated
-
March 31, 2026
New
Principles on Development of Combination Ophthalmic Solutions for Glaucoma (Early Consideration),Considerations for Pre-specifying the Change Categories for Manufacturing Process Parameters Identified as Established Conditions for Drug Products (Chemical Products) (Early Consideration) posted
-
March 27, 2026
Drug
Regen.
New
Document-based Inspection to CTD M3(Quality studies)/M4(Non-clinical studies other than GLP studies) data page created
-
March 25, 2026
Drug
IVD
Evaluation Report on Applicability to Drug-agnostic Companion Diagnostics,posted
-
March 25, 2026
Drug
The information of New Drug Review with Electronic Data updated
Currently, there is no applicable information.
