According to the official website of the State Food and Drug Administration, on October 26, the State Food and Drug Administration issued a newly revised Administrative Measures for Drug Recall (hereinafter referred to as the Measures), which will come into force on November 1. It is reported that the new version of the Measures highlights the main responsibility of the holder of the drug marketing license (hereinafter referred to as the holder), and adjusts the implementation subject of the recall from the drug manufacturer to the holder according to law; Further refine the scope of drug recall; Make more operational handling requirements for recalled drugs; Strengthened the connection between drug recall and drug traceability, information disclosure and other related work; Make corresponding provisions on overseas drug recall. Which drugs need to be recalled? Drug recall refers to the activities in which the holder takes back the listed drugs with quality problems or other potential safety hazards according to the prescribed procedures, and takes corresponding measures to control risks and eliminate potential safety hazards in a timely manner. The new version of the Measures includes 33 articles in five chapters, including general provisions, investigation and evaluation, active recall, ordered recall, and supplementary provisions. Specify that the holder is the responsible subject for controlling risks and eliminating hidden dangers. According to the provisions of the new version of the Measures, the holder shall actively publish the drug recall information according to law. For the implementation of the first level and second level recalls, the holder shall also apply to publish the recall information on the local provincial drug regulatory department website according to law. The drug recall information published by the provincial drug regulatory department shall be linked to the website of the State Food and Drug Administration. The relevant person in charge of the State Food and Drug Administration said that quality problems or other potential safety hazards refer to drugs that do not meet legal requirements due to research, production, storage, transportation, labeling and other reasons, or other unreasonable risks that may endanger human health and life safety. Including quality problems or other potential safety hazards caused by drug development, production, storage, transportation, labeling and other reasons, non-compliance with current drug quality management specifications such as Good Manufacturing Practice (GMP), Good Supply Practice (GSP), and incomplete label specifications. The drugs that have been legally sealed up or detained by the drug regulatory department according to the provisions of the Drug Administration Law when there is evidence that they may endanger human health are not included in the recall scope of these Measures. How should recalled drugs be handled? The new version of the Measures scientifically improved the handling measures for recalled drugs, and made it clear that the labeling and storage measures of recalled drugs should be significantly different from normal drugs to prevent errors and confusion; If it is necessary to destroy the drugs, they shall be destroyed under the supervision of the drug regulatory department or notary institution of the people's government at or above the county level in the holder, the drug manufacturer or the place where the recalled drugs are stored. The relevant person in charge of the State Food and Drug Administration said that the holder can choose to destroy under the supervision of the local drug supervision and administration department or notary institution according to his own actual situation, and it is unnecessary to return the drugs circulating nationwide to the holder's location for destruction, so as to reduce unnecessary storage and transportation costs. In principle, recalled drugs cannot be re marketed. However, if the hidden dangers can be eliminated by changing the label, modifying and improving the instructions, repackaging, etc., or if the prepared slices of traditional Chinese medicine do not meet the drug standards but do not affect the safety and effectiveness, and the problems can be solved by reworking, etc., appropriate measures can be taken to deal with them before they are put on the market. Relevant treatment operations should conform to the quality of corresponding drugs
Edit：qihang Responsible editor：xinglan
Source：People.cn
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