Drug Evaluation Committee The Future of Clinical Research undergoing a Transformation October 2022
Clinical Evaluation Subcommittee
October 2022
In March 2015, the Clinical Evaluation Subcommittee of the Committee on Drug Evaluation published two papers with recommendations on new laws and regulations for clinical research and a new clinical trial system. Subsequently, when the Clinical Research Act went into effect in April 2018, the committee wrote an editorial paper on the expectations and challenges of the new law, and a year later, it wrote a paper on the impact of the Clinical Research Act on pharmaceutical companies. In addition, in October 2020, we are finalizing a paper examining the regulatory issues of drug regulation and clinical research in novel coronavirus infections.
The Clinical Research Sub-team of the FY2022 Ongoing Issues Response Team-1 has now compiled a new paper examining the state of pharmaceutical approval in Japan, based on the expectations and challenges of the new emergency approval system introduced by the May 2022 amendment of the Pharmaceuticals and Medical Devices Act. This paper is based on the outline of the emergency approval system as outlined in the "Summary on the Approval System for Pharmaceuticals and Medical Devices in Emergency Situations" (December 27, 2021) compiled by the Pharmaceuticals and Medical Devices System Committee of the Health Sciences Council, and the "Approval Review Approach in the Emergency Approval System" (May 20, 2022, Pharmaceutical Affairs Council Hearing No. 0520-1) issued with the amendment of the law. The Clinical Evaluation Subcommittee is responsible for the clinical evaluation of clinical research.
The Clinical Evaluation Subcommittee will continue to study the effective use of evidence from clinical research.
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