"On further strengthening the drug clinical trial data inspection inspection notice

The 2016-01-04

national health and population and family planning commission of the People's Republic of China

Recently, the state food and drug supervision bureau issued "on further strengthening the drug clinical trial data comprehensive inspection notice, including drug clinical trial institution (medical institutions), relevant organizations and personnel work demands are put forward. Around to inform the family planning administrative department of public health and the medical institutions of drug clinical trials, to do a good job of inspection check data, national health commission decided to forward the file and request relevant work. Mainly includes:

First, to the family planning administrative department of public health with the food and drug supervision departments to do a good job of drug clinical trial data check list for verification. Confirmed by survey data of fraud, according to the regulations on the administration of medical institutions and its detailed rules for the implementation and the professional medical practitioners law to deal seriously with medical institutions and related physician.

Second, ask the family planning administrative department of public health at the provincial level shall, in accordance with the provisions of the trial of drug clinical trial institution qualification within their respective jurisdictions, strictly control to the application for qualification of medical institutions.

Third, required the family planning administrative department of public health at the provincial level according to the responsibility for drug clinical trial institutions within their respective jurisdictions in daily supervision and inspection, to strengthen the experimental clinical medical activities such as drug clinical trial management, ensure medical safety.

Relevant link: national health and family planning commission on forwarding the food and drug supervision bureau on further strengthening the drug clinical trial data check list inspection notice