Japan Clinical Trials

Showing 1–16 of 18 results

Japan’s PMDA: Clinical Study Data on Medical Devices from Foreign Clinical Studies
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Ministerial Ordinance 161: Good Clinical Practice (GCP) for Drugs in Japan
$180.00 Add to cart
Ministerial Ordinance No. 36: Good Clinical Practice for Medical Devices
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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
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PFSB No. 1121-15: Applications for Marketing Approval of In Vitro Diagnostics
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PFSB-ELD No. 0404-1: Guideline on Data Monitoring Committee
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PFSB-ELD No. 0928010-Basic Principles of Global Clinical Trials in Japan
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PMDA: Basic Principles of Risk-based Monitoring
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PMDA: Basic Principles on Global Clinical Trials (Reference Cases)
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PMDA: Guideline Pharmacokinetic and Pharmacodynamic Analysis
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PSEHB 0608-4/2020 Guideline for Exposure-Response Analysis of Drugs
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PSEHB No. 0122-7 – Clinical Trials Conducted on Ethical Grounds
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PSEHB No. 0731-1 : Conditional Early Approval System for Innovative Medical Devil Products (Fast-Break Scheme)
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Japan’s PMDA: Clinical Study Data on Medical Devices from Foreign Clinical Studies

Ministerial Ordinance 161: Good Clinical Practice (GCP) for Drugs in Japan

Ministerial Ordinance No. 36: Good Clinical Practice for Medical Devices

Ministerial Ordinance No.21 – Good Laboratory Practice for Nonclinical Safety Studies of Drugs

Ministerial Ordinance on Good Clinical Practice for Drugs

Ministerial Ordinance on Good Laboratory Practice for Nonclinical Safety Studies of Medical Devices

Notification 743/1998 : Guideline for Clinical Evaluation of Antibacterial Drugs

PFSB No. 1121-15: Applications for Marketing Approval of In Vitro Diagnostics

PFSB-ELD No. 0404-1: Guideline on Data Monitoring Committee

PFSB-ELD No. 0928010-Basic Principles of Global Clinical Trials in Japan

PMDA: Basic Principles of Risk-based Monitoring

PMDA: Basic Principles on Global Clinical Trials (Reference Cases)

PMDA: Guideline Pharmacokinetic and Pharmacodynamic Analysis

PSEHB 0608-4/2020 Guideline for Exposure-Response Analysis of Drugs

PSEHB No. 0122-7 – Clinical Trials Conducted on Ethical Grounds

PSEHB No. 0731-1 : Conditional Early Approval System for Innovative Medical Devil Products (Fast-Break Scheme)

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