Japan
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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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Guidance for Eval of (AI) Assisted Systems
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Japan PMDA (PFSB-ELD No. 0928010) : Basic Principles of Global Clinical Trials in Japan
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Japan PMDA: Application for Marketing Authorization for Medical Devices in Japan
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March 26, 2025 Office of New Drug II Pharmaceuticals and Medical Devices Agency
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Marketing Application – Home use MD for Diagnostic
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MHLW-PFSB No. 0331002 :Timeline for New Drug Applications
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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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Ministerial Ordinance on Good Clinical Practice for Drugs
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Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices
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Notification 743/1998 : Guideline for Clinical Evaluation of Antibacterial Drugs
Original price was: $15.00.$14.00Current price is: $14.00. Add to cart
