Drug Evaluation Committee Pharmaceutical Manufacturers Association of Japan Q&A on "Regulations for Enforcement of the Clinical Research Act and the Clinical Research Act
Medical Affairs Subcommittee
August 2019
This Q&A presents the Committee's views on questions received regarding the Clinical Research Act and the Enforcement Regulations for the Clinical Research Act at this point in time.
We request that you take appropriate measures in accordance with the relevant laws, regulations, and related notices, as well as this Q&A, with regard to clinical research and clinical trials to which the Clinical Research Act applies that are currently being conducted or are scheduled to be supported or conducted in the future.
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