Solicit the "Measures for the Supervision and Administration of Drug Operation and Use Quality"

Improve the main body and responsibilities of MAH, strengthen supervision, and keep pace with the times On November 12, the official website of the State Food and Drug Administration posted a public notice soliciting opinions on the "Measures for the Supervision and Management of Drug Operation and Use Quality (Draft for Solicitation of Comments)"
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According to the notice, in order to implement the "Pharmaceutical Administration Law of the People's Republic of China", the State Drug Administration organized the drafting of the "Measures for the Supervision and Administration of Drug Operation", which was publicly solicited from the public in September 2019
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The "Measures for the Supervision and Administration of Drug Operation and Use Quality" have been revised and perfected and are now again open to the public for comments
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If you have any feedback, you can send your feedback to the Comprehensive Supervision Department of the State Drug Administration before November 26, 2021
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The "Drug Administration Law" was approved by the National People's Congress in 2019, and came into effect on December 1, 2019
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Therefore, the draft "Measures for the Supervision and Administration of Drug Operation and Use Quality", which is currently solicited for comments, has been improved and revised on the basis of the newly revised "Drug Administration Law"
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The "Measures for the Supervision and Administration of Drug Operation and Use Quality (Draft for Comment)" was revised and revised in October 2021, and is divided into seven chapters: General Provisions, Business License, Operation Management, Drug Use Quality Management, Supervision and Inspection, Legal Responsibility, and Supplementary Provisions A total of 89 articles
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The purpose of the management measures is to strengthen the supervision and management of drug business and use, standardize the quality management of drug business activities and drug use links, and the supervision and management of drug business and use quality management within the territory of China are all applicable to these measures
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Compared with the previous draft for soliciting opinions, this draft of the opinion has improved the new ideas and first methods for the main body of drug business under the MAH system of the "Drug Administration Law"
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For example, the draft opinion clearly stated that the holders of the drug marketing authorization can sell the drugs they have obtained the drug registration certificate on their own, or they can entrust drug dealers to sell them
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If the holder of a drug marketing license is engaged in drug retail activities, it shall obtain a drug business license
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In the new crown epidemic since 2020, some new regulatory situations have also emerged, such as the suspension of sales of cold and fever drugs sold in retail pharmacies to control potential risks
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The opinion draft also reflects the basis of this regulatory measure
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The draft opinion shows: In the event of a public health emergency or other emergency that seriously threatens public health, pharmaceutical retail companies should strictly abide by the emergency response regulations of the people's governments at all levels, and take measures such as removing products from shelves and suspending sales as required
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Set up a negative list for certain drugs
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It is clarified that pharmaceutical trading enterprises shall not sell vaccines, Chinese medicine formula granules, and other drugs that are prohibited by the state from pharmaceutical trading enterprises
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Drug retail enterprises shall not sell narcotic drugs, first-class psychotropic drugs, radioactive drugs, pharmaceutical precursor chemicals, anabolic agents, peptide hormones (except insulin), and pregnancy termination drugs
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For retail enterprises, it is again emphasized that prescription drugs and Class A non-prescription drugs should not be given to the public by means of buying drugs as gifts or buying commodities as gifts
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Prescription drugs cannot be sold on the shelves
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Clarify cross-regional regulatory responsibilities.
For example, if the drug listing holder, operating company and the entrusted party entrusted to carry out drug business activities are not in the same province, region or city, the drug regulatory authority where the entrusting party and the entrusted party are located shall be responsible for the supervision of both parties, and strengthen information communication , Carry out joint inspections when necessary
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Regarding the establishment of warehouses in different places by drug trading enterprises, the enterprises can apply for approval to the drug regulatory department of the registered place to deal with the permission items for the change of warehouses
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The drug regulatory department of the registered place is responsible for the supervision of warehouses in other places, and the drug regulatory department of the warehouse is responsible for daily supervision
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In addition, the solicitation draft also conveys the trend of strengthening supervision in the future, clarifying the frequency of inspections, the connection of discipline and punishment, law enforcement and joint punishment
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No less than two inspections per year for poison, hemp, and first-grade drugs; no less than once a year for refrigerated and frozen drugs, second-grade drugs, and toxic drugs; no less than once a year for vaccine receiving and storage institutions, etc.

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When the drug regulatory department discovers suspected violations of laws and regulations during supervision and inspection, it shall take control measures in a timely manner and investigate and deal with them in accordance with their duties and powers.
If suspected of violations of laws and disciplines, they shall be transferred to relevant departments
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During the supervision work, the drug regulatory department shall not hinder the normal production, operation, and diagnosis and treatment activities of license holders, manufacturing enterprises, operating enterprises, and medical institutions
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Of course, for those with bad credit records, the frequency of supervision and inspection should be increased, and joint punishments can be implemented in accordance with regulations
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