Clinical Trials in Japan
Japan is the world’s second-largest single-country pharmaceutical market, accounting for approximately 10 percent of global drug sales, and is expanding quickly. Sponsors of clinical trials must conduct the following standards specified in the Ministry of Health, Labour and Welfare (MHLW) ordinance.
General Clinical Trials in Japan
Document Title | Issued by | Description | Available Languages | Download |
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PMDA: Clinical Trials Conducted on Ethical Grounds : Japanese Compassionate Use System | PMDA | Programs such as the “Expanded Access Program” and the “compassionate use” system, have been established in the United States and Europe on ethical grounds to provide unapproved drugs for the treatment of fatal diseases with no alternative therapeutic agents. | English | For Sale |
PMDA: Guideline on Data Monitoring Committee | PMDA | This guideline intends to provide general guidance, at the current moment, related to the necessity, role, establishment, and management of a data monitoring committee (DMC) in a clinical study (trial) of a drug or medical device. | English | For Sale |
PMDA: Basic Principles of Risk-based Monitoring | PMDA | The Guidance on Ministerial Ordinance on Good Clinical Practices referred to as the Guidance on GCP. indicates that not all clinical trial data has to be verified against the source data for trial monitoring. Introduction of this kind of risk-based monitoring is expected to increase efficiency of trial operations as well as to ensure safety of the subjects and the integrity of clinical trials. | English | For Sale |
PMDA: Basic Principles on Global Clinical Trials (Reference Cases) | PMDA | “Basic Principles on Global Clinical Trials” had been issued based on the knowledge accumulated through the clinical trial consultations of Pharmaceuticals and Medical Devices Agency. | English | For Sale |
Clinical Trials for Pharmaceuticals
Document Title | Issued by | Description | Available Languages | Download |
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PMDA: Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis | PMDA | The “Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis” has been published in the “Notification of Guideline on Population Pharmacokinetic and Pharmacodynamic Analysis” | English | For Sale |
PMDA: Guideline for Clinical Evaluation of Antibacterial Drugs | PMDA | A guideline for clinical studies of antibacterial drugs aimed to conduct for marketing approval . | English | For Sale |
Clinical Trials for Medical Devices
Document Title | Issued by | Description | Available Languages | Download |
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Clinical Study Data on Medical Devices from Foreign Clinical Studies | PMDA | Guideline on handling of data on the clinical studies for medical devices conducted in the foreign countries or regions, | English | For Sale |