Medical Research & Clinical Trials

Funding body

The Japan Agency for Medical Research and Development (AMED) is an institution that aims to conduct operations such as research and development (R&D) in the medical field, improvement of the R&D environment and promotion of R&D.
AMED supports research studies conducted by universities and research institutions in order to promote seamless medical R&D extending from basic research to practical application and facilitate practical application of the results.

  • Japan Agency for Medical Research and Development

Regulatory agency

The Pharmaceuticals and Medical Devices Agency (PMDA; Pharmaceuticals and Medical Devices Agency) aims to contribute to the improvement of public health. It aims to promptly relieve the adverse effects of pharmaceuticals and the health hazards due to bio-derived products caused infections. In addition, PMDA provides guidance and review of the quality, efficacy, and safety of pharmaceuticals, medical devices, etc. through a system that integrates the entire process from pre-clinical study to approval, and collect, analyze, and provide information on post-marketing safety. PMDA conducts approval review, post-marketing safety measures and relief services for adverse health effects.

  • Pharmaceuticals and Medical Devices Agency

Regulatory Information

1.Clinical Trials Act

The “Clinical Trials Act” is a law applicable to clinical trials conducted to reveal the efficacy and safety of a pharmaceutical product in humans.
The Act stipulates the procedures for the conduct of clinical trials, measures for appropriate conduct of reviewing operations by a certified clinical trial review board and a system for publication of clinical trial information, including information on funding, in order to promote the conduct of clinical trials through securing the confidence of the nation, including clinical trial subjects, on clinical trials and contribute to the improvement of public health and hygiene.

2.Advanced Medical Care System

The Advanced Medical Care System establishes certain institutional standards for each medical technology and allows patients to receive benefits from the combined use of such technology with treatment covered by insurance at authorized insurance medical institutions satisfying the institutional standards in response to their requests, with the view to ensuring public safety, preventing increased burden on patients, giving the public greater selection, and improving convenience.
The Advanced Medical Care System is also positioned as an evaluation system for the introduction of insurance coverage of new treatments in the future.

  • RegulatorychangesaftertheenforcementofthenewClinicalTrialsActinJapan.pdf

3.System for Patient-Requested Medical Treatment

The system for Patient-Requested Medical Treatment enables patients to access advanced medical care promptly at a local medical institution with proper safety and efficacy monitoring in response to requests from patients who desire to try new treatments, including unapproved drugs.
The system is designed to collect data and scientific evidence that will lead to insurance coverage of the new treatments in the future.

  • MedicalExpensesCombinedwithTreatmentOutsideInsuranceCoverage(en).pdf

4.Pharmaceutical affairs system

The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the Pharmaceuticals and Medical Devices Act) is a law established to improve health and hygiene by providing the control required for securing the quality, efficacy and safety of pharmaceuticals, quasi-pharmaceutical products, cosmetics, medical devices, regenerative medicine products and for preventing the occurrence or spread of health and hygiene-related hazards caused by their use, by taking measures against designated substances, and by taking necessary measures for the promotion of research and development of pharmaceuticals, medical devices and regenerative medicine products which fulfill particularly high medical needs.

  • Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

5.Guidelines

5-1.Ethical Guidelines for Life Science, Medical and Health Research Involving Human Subjects

The content on "Ethical Guidelines for Life Science, Medical and Health Research Involving Human Subjects" will be posted on the site after the revision of the guideline.

5-2.Ethical Guidelines for Human Genome / Genetic Analysis Research

The content on " Ethical Guidelines for Human Genome / Genetic Analysis Research" will be posted on this site after the revision of the guideline.

5-3.Guidelines for Clinical Study of Gene Therapy

The Guidelines for Clinical Study of Gene Therapy stipulate compliance rules on clinical studies of gene therapy in order to ensure medical benefits and ethics of clinical studies of gene therapy and secure proper implementation of the studies in a manner open to the public.

  • GuidelinesforClinicalStudyonGeneTherapy.pdf

CONTACT

If you wish to collaborate on a listed project, or if you wish to propose a joint research project, please fill in the Contact Form and submit it.