According to the official website of the State Food and drug administration, recently, the State Food and Drug Administration publicly solicited opinions on the newly revised Measures for the supervision and administration of the quality of drug distribution and use (Draft for comments) (hereinafter referred to as the draft for comments). Among them, the draft stipulates that drug retail enterprises should abide by the national classified management system for prescription drugs and over-the-counter drugs, sell prescription drugs by prescription according to regulations, and keep the prescription for no less than five years. Drug retail enterprises shall not give prescription drugs or class a over-the-counter drugs to the public by buying drugs as gifts or buying commodities as gifts. Prescription drugs shall not be sold on open shelves. The draft is divided into seven chapters, including general provisions, business license, business management, drug use quality management, supervision and inspection, legal liability and supplementary provisions, with a total of 89 articles. The draft requires that drug trading enterprises should establish a drug trading quality management system covering the whole process of drug trading. Purchase and sales records, storage conditions, transportation process, quality control and other records shall be complete and accurate, and shall not be fabricated or tampered with. The holder of drug marketing license shall establish and improve the drug traceability system according to regulations, assign traceability marks to the sales packaging units at all levels of listed drugs, and implement the whole process traceability management of drugs. According to the draft, drug trading enterprises shall not sell vaccines, traditional Chinese medicine formula granules and other drugs prohibited by the state. Drug retail enterprises shall not sell narcotic drugs, class I psychotropic drugs, radioactive drugs, drug precursor chemicals, protein assimilation agents, peptide hormones (except insulin) and drugs for termination of pregnancy. The relevant qualification materials and purchase and sales records in the purchase and sales activities of drug marketing license holders and drug trading enterprises shall be kept for more than one year and not less than five years. The draft clearly states that in case of public health emergencies or other emergencies that seriously threaten public health, drug retail enterprises shall strictly abide by the emergency disposal provisions of people's governments at all levels and take measures such as removing goods from the shelves and suspending sales as required. The draft also defines the responsibility of cross regional supervision. If the holder of the drug marketing license, the drug handling enterprise and the trustee entrusted to carry out drug trading related activities are not in the same province, autonomous region or municipality directly under the central government, the drug regulatory department of the province, autonomous region or municipality where the drug marketing license holder and the drug handling enterprise are located shall be responsible for the supervision and administration of the holder of the drug marketing license and the drug handling enterprise, The drug regulatory department of the province, autonomous region or municipality directly under the central government where the trustee is located shall be responsible for the supervision and administration of the trustee. Both parties shall strengthen information communication, timely inform each other of supervision and inspection, and carry out joint inspection when necessary. The State Food and Drug Administration said that in order to implement the drug administration law of the people's Republic of China, the State Food and Drug Administration organized the drafting of the measures for the supervision and administration of drug trade, and solicited opinions from the public in September 2019. The measures for the supervision and administration of the quality of drug distribution and use have been revised and improved, and are now open to the public for comments again. Please feed back relevant opinions to the via email before November 26, 2021 ypjgs@nmpa.gov.cn Please indicate "feedback on drug distribution and use measures" in the email title. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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