Drug Evaluation Committee The Future of Clinical Research undergoing a Transformation October 2020
Clinical Evaluation Subcommittee
October 2020
In March 2015, the Clinical Evaluation Subcommittee of the Drug Evaluation Committee compiled recommendations on new laws and regulations for clinical research and new clinical trial systems in two papers. In addition, when the Clinical Research Act went into effect in April 2018, an editorial on the expectations and challenges of the new law was published in a paper, followed a year later by a paper on the impact of the Clinical Research Act on pharmaceutical companies.
The Clinical Research Subteam of the FY2020 Ongoing Issues Response Team-1 has now compiled a new paper examining the regulatory issues of drug regulation and clinical research in novel coronavirus infection (COVID-19). This paper is based on the regulatory responses in Japan, the U.S., and Europe in the approval of COVID-19 therapeutics.
The Clinical Evaluation Subcommittee will continue to study the effective use of evidence from clinical research.
Deliverables of the Drug Evaluation Committee Return to list of all deliverables