Quality management specification for drug clinical trials

On May 6, the national medical product administration and the national health and Health Commission issued the new “quality management specification for drug clinical trials”, which is applicable to drug clinical trials for drug registration, and shall come into force as of July 1, 2020.  Clinical trials of drugs should conform to the principles of the declaration of Helsinki of the world medical congress and relevant ethical requirements. The documents that should be reviewed by the Ethics Committee include: the trial scheme and the revised trial scheme; informed consent and its updates; ways and information of recruiting the subjects; otherRead More →

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