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.

Document Title Issued by Description Available Languages Download
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
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
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