Japan Health Authority PMDA
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Administrative Notice January 25, 2024 Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars (PSEHD/PED) Notification No. 0204, Ministry of Health, Labour and Welfare (MHLW), dated February 4, 2020
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Ministerial Ordinance 136: Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices
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Ministerial Ordinance No. 36: Good Clinical Practice for Medical Devices
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Ministerial Ordinance No.2 Regulations for Facilities of Pharmacies in Japan
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Ministerial Ordinance No.21 – Good Laboratory Practice for Nonclinical Safety Studies of Drugs
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PFSB/ELD Notification No. 0527-1,2010 Vaccines Against the Novel Coronavirus SARS-CoV-2
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PFSB/ELD Notification No. 1228-7 Basic Principles of Risk-based Monitoring
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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-CPE No.1116002: Procedure for Remote Inspection for Drugs & Regenerative Products
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PMDA-PSEHB-MDED No. 0709-2: Ensuring the Quality and Safety of Gene Therapy Products
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Provisional Translation (as of December 2024) PFSB/ELD Notification No. 0214-1 February 14, 2013
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