The Measures for the Administration of Drug Recall, which came into effect on July 1, 2021, aim to standardize the drug recall procedure and accountability, and safeguard the public's drug safety. The Measures strengthen the supervisory and management responsibilities of the regulatory authorities for drug recalls, and prevent or reduce safety risks in the use of medicines in conjunction with the construction of a long-term mechanism for national drug safety. Drug recall applies to the discovery of serious defects, adverse reactions and other safety risks of drugs, the relevant enterprises must immediately start the recall procedure, report to the regulatory authorities, and be responsible for the results of the treatment after the recall. The recall procedure mainly includes the following links: 1. Problem discovery: Drugs are found to have serious defects, adverse reactions and other safety risks in the production, circulation and use of drugs. 2. Preliminary assessment: Enterprises conduct preliminary assessment of the defects and adverse reactions of drugs to determine whether a recall is necessary. 3. Decision-making on recall: Enterprises decide whether or not to recall drugs based on the results of the preliminary assessment and report them to the supervisory authorities. 4. Implementation Recall: The enterprise initiates the recall procedure, notifies relevant sales units, distributors, medical institutions and other affected parties, and takes necessary measures to ensure that the recall goes smoothly. 5. Handling of recall: The enterprise disposes of the recalled medicines (destroys or re-processes them), and at the same time reports the results of the post-recall processing to the regulatory authorities. For enterprises and responsible personnel who fail to stop selling and recall defective drugs in time, and are involved in drug safety accidents and other dereliction of duty and malfeasance, the regulatory authorities will pursue their relevant responsibilities in accordance with the law, including fines, revocation of licenses, and other administrative penalties, as well as criminal liability prosecution.
What medicines are subject to the recall? The recall measures apply to all medicines registered in China, including traditional Chinese medicines, chemical medicines and other types of medicines, regardless of the type of approval number and country of origin, as long as they pose a safety risk, they need to start the recall process.
The implementation of the administrative measures for drug recall is conducive to standardizing the drug recall procedure and accountability, and promoting public drug safety. Pharmaceutical companies should strictly fulfill their legal obligations during the production, distribution and use of medicines, and strengthen their quality management capabilities to ensure the quality and safety of medicines. The public should also raise awareness of medication safety, use medication as prescribed by doctors, and choose medications carefully to avoid health problems caused by improper use of medication.
Legal basis:
Article 20 of the Administrative Measures for Drug Recall of the People's Republic of China and the People's Republic of China Drug recall shall ensure timely, effective and comprehensive, and the data, documents, information and situation of drug recall shall be disclosed to the public, and the legitimate rights and interests of those involved in the recall and the relevant enterprises shall be protected.