Medical institutions must not use personally-carried inbound drugs

The State Food and Drug Administration issued a notice on October 18 requesting medical institutions to purchase and use drugs approved by the State Food and Drug Administration, and not to purchase or use medicines brought into China by individuals.

Recently, Shanghai First People’s Hospital had an incident involving eye discomfort caused by the use of drugs that had not been approved by the State Food and Drug Administration and were brought into the country by individuals. In order to protect the public's drug safety and avoid similar incidents, the State Food and Drug Administration issued the Notice on Strengthening the Administration of the Import and Use of Pharmaceutical Medical Devices.

The notification clearly clarified that medical institutions must purchase pharmaceuticals approved by the State Food and Drug Administration from enterprises that have the qualifications for the production and operation of pharmaceuticals, and strictly prohibit purchases from enterprises and individuals without a Pharmaceutical Production License or a Pharmaceutical Trade License. Into the drug. All purchases of medicines that have not been approved by the State Food and Drug Administration shall be treated as counterfeit medicines. Suspected of committing a crime, it shall be transferred to judicial organs for criminal responsibility.

At the same time, medical institutions should purchase qualified medical devices from the production enterprises that have obtained the License for Medical Device Manufacturing Enterprises or the enterprises that have obtained the License for Medical Device Operation Enterprises, and verify the product's certificate of conformity. Do not use medical devices that have not been registered, have no certification, have expired, have expired, or have been phased out.

The notification requires that the import of clinically urgently needed drugs must be approved by the State Food and Drug Administration, and the relevant import filing formalities should be handled with the "Approved Import Drugs" issued by the State Food and Drug Administration. In the development of new drugs, relevant information shall be submitted in accordance with the relevant provisions of the Drug Registration Administration Act, and clinical trials may be conducted only after approval, and the execution of clinical trials must meet the requirements of the "Quality Control Practice for Drug Clinical Trials".

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