Japan
Showing 17–32 of 33 results
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PMDA Guideline: Master File System for Drug Substances (MF) in Japan
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PMDA Guideline: Application for Accreditation of Foreign Manufacturers (FMA) to PMDA in Japan
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PMDA Guideline: Conditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme) in Japan
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PMDA Guideline: Cosmetic Standards in Japan
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PMDA Guideline: List of Active Ingredients in Medicinal Cosmetics in Japan
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PMDA Guideline: Nanotechnology Cosmetic in Japan
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PMDA Guidelines: Clinical Study Data on Medical Devices from Foreign Clinical Studies in Japan
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PMDA Guidline: Applications for Marketing Approval related to the Handling of Medical Device Software in Japan
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PMDA Notification No.171/2004: Procedures for Developing Post-marketing Study Plan
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PMDA: Points to Consider for Reprocessed Single-use Medical Devices
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Provisional Translation (as of December 2024) PFSB/ELD Notification No. 0214-1 February 14, 2013
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PSEHB 0608-4/2020 Guideline for Exposure-Response Analysis of Drugs
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PSEHB No. 0731-1 : Conditional Early Approval System for Innovative Medical Devil Products (Fast-Break Scheme)
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PSEHB No.0201: Applications for Marketing Approval related to the Period of Transitional Measures with respect to the Handling of Medical Device Software
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PSEHD/PED Notification No.0204-1 February 4, 2020 Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics (PFSB/ELD Notification No. 0304007
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Transfer of Marketing Authorization in Japan
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