General office of the national health and family planning commission on further notice "self audits" on a drug clinical trial institution

The 2015-11-16 national health and population and family planning commission of the People's Republic of China

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Provinces, autonomous regions and municipalities directly under the central government health and family planning commission, the xinjiang production and construction corps health bureau:

According to the state food and drug supervision and administration bureau, the national health and family planning commission, the general logistics department of the ministry of health on the drug clinical trial institution inspection notice "(no. 197, 2015, hereinafter referred to as the" notice ") requirements and one of the first clinical trial data verification results, eight enterprises 11 drug clinical trial registration data is not real and incomplete problems. The drug clinical trial institution respectively in guangzhou psychiatric hospital, union hospital affiliated to tongji medical college huazhong university of science and technology, bengbu medical college affiliated hospital, qilu hospital of shandong university, liaoning university second affiliated hospital of traditional Chinese medicine. In order to further do a good job in drug clinical trial institution self checking and strengthen the management of medical institutions, will now about that notice the following:

, relevant provincial family planning administrative department of public health to cooperate with local food and drug regulatory department of the hospital. According to the survey results, on the basis of 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 physicians, and the results submitted by commission.

Second, take drug clinical trial institutions in accordance with the "notice" requirement, earnestly "self audits" on a drug clinical trials, timely discover and correct problems. To strengthen the medical documents in accordance with the relevant provisions and drug clinical trial data and other relevant information management, ensure each work orderly.

Three, place the family planning administrative department of public health at various levels shall strengthen the daily supervision of medical institutions, medical safety hidden trouble in time and irregularities, and crack down on all illegal behavior, ensure medical safety, protecting the health of the people's rights and interests.

General office of national health and family planning commission

On November 13, 2015

Relevant link: to carry out the drug clinical trial institution inspection notice