Interpretation of the Measures for the Supervision and Administration of Drug Circulation from the Measures for the Supervision and Administration of Drug Circulation

In order to further strengthen the supervision of the drug market, standardize the order of drug circulation, and ensure the safety of public medication, the State Food and Drug Administration of the United States recently promulgated the newly revised Measures for the Supervision and Administration of Drug Circulation (hereinafter referred to as the Measures, for the full text, see A4 version of this newspaper on February 8). These Measures shall come into force as of May this year 1 day. Recently, our reporter interviewed the relevant person in charge of the US Food and Drug Administration on the revision background, revision process, revision principles and main contents of the Measures. Reporter: What is the background and significance of the revision of the Measures by the US Food and Drug Administration? Responsible person: We should fully understand the significance of revising the Measures from the perspective of comprehensively promoting administration according to law, standardizing and rectifying the order of drug circulation. The Measures for the Supervision and Administration of Drug Circulation (Provisional) (Order No.7 of the State Pharmaceutical Products Supervision and Administration Bureau) was promulgated on 1 June, 1999 and officially implemented on1August of the same year. Since its implementation, it has played an important role in strengthening drug market supervision, rectifying and standardizing drug circulation order, and ensuring public drug safety. However, in recent years, great changes have taken place in China's drug market, circulation mode and regulatory focus. For example, some drugs are in disorder, and criminals take the opportunity to sell fake and inferior drugs; Unlicensed operators participate in drug business activities; Preparations from medical institutions enter the circulation field; Drug retail enterprises illegally sell prescription drugs; Some illegal business operators engage in illegal drug business activities in the name of pharmaceutical production and operation enterprises by means of affiliation, etc. Especially after the promulgation and implementation of the revised Drug Administration Law, the legislative basis of the Interim Measures for the Supervision and Administration of Drug Circulation has changed. Therefore, according to the current Drug Administration Law, the Regulations for the Implementation of the Drug Administration Law and the reality of drug circulation supervision, it is imperative to revise the Interim Measures for the Supervision and Administration of Drug Circulation. Reporter: It is understood that the revision of the Measures has gone through a process of repeated investigation and revision. Can you briefly introduce the revision of the Measures? Person in charge: Because the Measures involve all aspects of drug circulation, the State Food and Drug Administration of the United States attaches great importance to the revision of the Measures, and has organized several revision forums to listen to the opinions and suggestions of grassroots law enforcement comrades, administrative counterparts and legal experts, and draft and improve the Measures. In order to fully listen to the opinions of grassroots law enforcement personnel, since the first half of 20001,the Department of Drug Market Supervision has organized four revision seminars attended by grassroots law enforcement personnel, listened to opinions and suggestions, drafted and improved the draft of the Measures for comments, and distributed it to the drug regulatory departments of provinces (autonomous regions and municipalities) and relevant departments of the Bureau for comments. All localities attach great importance to the revision of the Measures and seriously organize grassroots law enforcement personnel to discuss and revise them. On the basis of extensively soliciting the opinions of the drug regulatory authorities, we also fully listened to the opinions of relevant associations and administrative counterparts. At the same time, some difficult problems in the process of drug circulation, such as the management of drug salesmen and the supervision of drug use in medical institutions, were also investigated. In May and July, 2004, two revision workshops were held, in which market supervisors and inspectors from some provinces (autonomous regions and municipalities) participated. After repeated discussion and research, more than ten drafts were revised. In order to widely listen to the opinions of the grassroots and all sectors of society on the revision of the Measures, the Policy and Regulation Department officially issued a document in June 2004 to solicit opinions from provincial, municipal and county food and drug administrations and administrative counterparts, and went online twice in June 2004+June 2006 and August 2006 to solicit opinions from all sectors of society; From June 5th to February 5th, 2004, a symposium was held for representatives of china association of pharmaceutical commerce, medical institutions and pharmaceutical production and marketing enterprises. In February 2004, 65438 and April 2006, two seminars were held for drug supervision and law enforcement personnel, and personnel from regulations, markets and inspection departments participated in the seminars. In June 2005, 165438+ 10, and in July 2006, we listened to the opinions of more than 200 directors of municipal and county food and drug administrations who participated in training in Beijing. The Policy and Regulation Department has communicated with NPC Law Committee and the State Council Legislative Affairs Office for many times on drug use supervision in medical institutions and drug use supervision in non-medical institutions. In June and June, 2006, legal experts from NPC Political and Legal Committee, the State Council Legislative Affairs Office, Ministry of Health, Population and Family Planning Commission, National School of Administration, China Academy of Social Sciences, Peking University, Tsinghua University, China University of Political Science and Law and other relevant departments and units were organized to hold special discussions. Therefore, the "Measures" were formed on the basis of repeated discussion, research and revision. Reporter: What principles have been followed in the revision of the Measures? Person in charge: During the revision of the Measures, our bureau has always adhered to the following three principles: First, it must comply with the provisions of the superior law. Where the current Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law have been clearly stipulated and are no longer reflected in the Measures, and are inconsistent with the above-mentioned laws and regulations, they shall be revised in accordance with the provisions of laws and regulations. Second, it conforms to the provisions of the Administrative Licensing Law. There are no specific provisions on administrative licensing matters not set by the superior law. The third is to be targeted and operable. According to the needs and development requirements of China's drug circulation supervision and combined with the reality of China's drug market, the Measures clarify the problems that are not clearly stipulated by laws and regulations but exist objectively in the field of drug circulation and need to be standardized and solved urgently. Reporter: What are the new contents compared with the Measures for the Supervision and Administration of Drug Circulation (Provisional)? Person-in-charge: The revised Measures deleted the provisions of the current superior law, or the contents inconsistent with the provisions of the superior law and the administrative licensing law, and added some new regulatory requirements in combination with the current situation of China's pharmaceutical market and the development needs of circulation supervision. Most of the new contents are common in drug circulation, but the Drug Administration Law and the Regulations for the Implementation of the Drug Administration Law are not clearly defined, which is an urgent problem for grassroots law enforcement. 1. In view of the variety and disorder of drug exhibitions and sales in recent years, in order to strengthen the supervision of drug exhibitions and sales, and prevent criminals from taking the opportunity to sell counterfeit and inferior drugs, disrupting the market order and operating drugs without a license, Article 15 of the Measures stipulates that pharmaceutical production and marketing enterprises shall not sell drugs in the form of exhibitions, fairs, trade fairs, order fairs and product promotion meetings. , and clarified the corresponding legal responsibilities. Second, in order to block the drug purchase channels of illegal operators from the source and solve the problems of irregular drug circulation order, unlicensed operators participating in drug trading activities and illegal drug trading, the Measures stipulate that pharmaceutical production and trading enterprises shall not provide drugs to others who know or should know that they are engaged in unlicensed drug trading. And made some specific regulatory requirements for drug production, business premises, purchase and sale personnel, purchase and sale channels, bill management and so on. Third, in order to strengthen the management of preparations in medical institutions and prevent preparations from entering the circulation field, the Measures clarify that pharmaceutical trading enterprises are not allowed to buy or sell preparations prepared by medical institutions, and formulate corresponding punishment measures. Fourth, in order to ensure the quality of drugs during transportation and storage, especially to ensure the integrity of the cold chain of vaccines and other drugs during transportation, and to prevent deterioration and failure, the Measures stipulate that drugs that require low-temperature storage and refrigeration in the drug instructions should be transported and stored by pharmaceutical production and marketing enterprises in accordance with relevant regulations. The fifth is to provide an important clue source for tracing, verifying and handling drug quality problems, and further standardize the records and behaviors of drug purchase and sale. The Measures stipulate that pharmaceutical production enterprises and pharmaceutical wholesale enterprises should issue sales vouchers indicating the name of the supplier, the name of the drug, the manufacturer, the batch number, the quantity and the price when selling drugs. When selling drugs, pharmaceutical retail enterprises shall issue sales vouchers indicating the name, manufacturer, quantity and price of the drugs. 6. In order to promote the classified management of prescription drugs and over-the-counter drugs, strengthen the sales management of prescription drugs in retail pharmacies, and clarify the legal responsibilities of retail pharmacies for illegally selling prescription drugs, the Measures stipulate that pharmaceutical retail enterprises should sell prescription drugs in accordance with the requirements of the drug classification management regulations of the State Food and Drug Administration of the United States, and stipulate corresponding illegal responsibilities. Seventh, in order to strengthen the management of drug procurement and storage in medical institutions, ensure the quality of drug use in medical institutions, and prevent counterfeit and inferior drugs from flowing into medical institutions, the Measures stipulate that medical institutions must establish and implement the incoming inspection and acceptance system in accordance with the Drug Administration Law and the Implementation Regulations of the Drug Administration Law, establish true and complete drug procurement records, and put forward clear requirements for the contents of their procurement records respectively. At the same time, it is stipulated that medical institutions should formulate and implement a drug storage and custody system, and take necessary measures such as refrigeration, antifreeze, moisture-proof, light-proof, ventilation, fire prevention, insect prevention and rat prevention to ensure the quality of drugs. Eighth, in order to strengthen the supervision of both buyers and sellers of drugs, and prevent some illegal operators from publicly setting up offices in the name of pharmaceutical production and marketing enterprises by means of affiliation, thus disrupting the normal order of drug circulation, the "Measures" used a large space in the second chapter, and made specific normative requirements for the offices and sales personnel of pharmaceutical production and marketing enterprises.