Regulations on drug clinical trial institutions

The National Medical Product Administration-NMPA and the National Health Commission-NHC jointly issued the regulations on the administration of drug clinical trial institutions, which shall come into effect on December 1, 2019. The organization of drug clinical trials has changed from qualification certification to filing management. It only carries out the analysis of biological samples related to drug clinical trials, and does not need to record. NMPA and NHC shall be responsible for the supervision and administration of the drug clinical trial institutions in accordance with their respective responsibilities. NMPA is responsible for the establishment of the “drug clinical trial institutionRead More →

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