Japan Pharmaceuticals
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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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MHLW-PFSB No. 0331002 :Timeline for New Drug Applications
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Sale!
Ministerial Ordinance 136: Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices
Original price was: $75.00.$60.00Current price is: $60.00. Add to cart -
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Ministerial Ordinance 161: Good Clinical Practice (GCP) for Drugs in Japan
Original price was: $200.00.$180.00Current price is: $180.00. Add to cart -
Ministerial Ordinance 179: Good Manufacturing Practices for Drugs
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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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Notification No. 0620-6 – Study Data for New Drug Applications
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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. 0611-1 June 11, 2012 Guideline for Clinical Evaluation of Diagnostic Radiopharmaceuticals
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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 Notification No.171/2004: Procedures for Developing Post-marketing Study Plan
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PMDA PFSB/ELD Notification No.899/2001: Points to Consider for Reducing Total Review Time for New Drug Applications
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PMDA-CPE No.1116002: Procedure for Remote Inspection for Drugs & Regenerative Products
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