What's new
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April 21, 2026
Safety
New
Revisions of PRECAUTIONS: Infliximab (genetical recombination) and biosimilars , etc. posted
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April 20, 2026
Int
New
A new page for the Regulatory Symposia has been launched.
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April 14, 2026
Safety
MHLW Pharmaceuticals and Medical Devices Safety Information No.428 posted
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April 14, 2026
Review
The information of New Drug Review with Electronic Data updated
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April 13, 2026
Events
The report for the PMDA-ATC Pharmacovigilance Seminar 2026 has been posted.
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April 13, 2026
Int
The report for the APEC CoE workshop: PMDA-ATC Pharacovigilance Seminar 2026 has been posted.
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April 13, 2026
Int
PMDA-ATC E-Learning Course contents have been released for FY2026
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April 13, 2026
Other
Recent Publications by PMDA Staff updated
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April 10, 2026
Review
Considerations for clinical development of intravenous formulations containing the same active ingredient as oral products for patients who are temporarily unable to receive oral administration in epilepsy treatment （Early consideration） posted
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April 8, 2026
Review
The English versions of Orange Letter No.10~12 have been published.
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April 14, 2026
Drug
The information of New Drug Review with Electronic Data updated
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April 10, 2026
Considerations for clinical development of intravenous formulations containing the same active ingredient as oral products for patients who are temporarily unable to receive oral administration in epilepsy treatment （Early consideration） posted
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April 8, 2026
Quasi
Drug
The English versions of Orange Letter No.10~12 have been published.
Currently, there is no applicable information.
