Clarify regulatory rules and improve the regulatory system -Promote the scientific and effective supervision of drug network sales

On September 1, the "Measures for the Supervision and Administration of Drug Network Sales" (hereinafter referred to as the "Measures") was officially released and will be implemented from December 1 this year. The introduction of the Measures further improved the regulations and regulations of my country's drug circulation links, and provided scientific guidance and powerful tools for Internet drug transaction supervision and law enforcement.

Substitute of main management

Lay the foundation for supervision

To do a good job of supervision of drug network sales, we must first determine the supervision objects, clarify management logic, and divide the responsibilities of all parties. The "Measures" set up a multi -dimensional main management method around the two types of participating entities of online sales enterprises and drug network transaction services.

>> Highlight the consistent online and offline, strengthen the supervision of online sales enterprises

In recent years, the industry has controversially controversial drug network sales, especially the legal subject of online retail. The Interim Provisions on the Approval of Internet Drug Transaction Services shall be implemented from December 1, 2005. It is clear that enterprises that provide Internet drug trading services to individual consumers should be pharmaceutical chain retail companies. The development level is consistent, and it has played a positive role in standardized management. However, with the advancement of "decentralization of service" and promoting policies such as "Internet+", the above provisions also need to keep pace with the times. In this regard, the second chapter of the "Measures" has optimized and expanded the qualified business entity, and clarified that the drug network sales enterprise includes a drug listing license holder (Chinese medicine drinking production enterprises selling the Chinese medicine drinks produced by it should fulfill the obligation of the holder) And pharmaceutical business enterprises, among them, companies that obtain drug retail qualifications can sell drugs to individuals through the Internet. At the same time, the "Measures" pointed out that pharmaceutical network sales enterprises should report to the drug regulatory department to carry out key information such as network sales and application names for online sales. This is unified with the spiritual connotation of Article 61 of the "Pharmaceutical Management Law of the People's Republic of China" in Article 61 "Pharmaceutical Listing License of Pharmaceuticals and Selling Drugs through the Internet, and shall comply with the relevant provisions of the drug management of this law". The management form of the report is a strong starting point for the grass -roots regulatory authorities to grasp the main body of the area to carry out pharmaceutical network operations, carry out the supervision of network operating behavior in targeted network operations, and improve corporate supervision files.

>> Highlight the platform of the platform and strengthen the supervision of mainstream channels

The third -party platform has the main active user resources of traffic entrances and networks. It is the mainstream channel for drug network sales. The standardized management of regulatory management is the focus and key of drug network sales supervision. The third chapter of the Measures clarifies the filing requirements of the third -party platform, incorporate the mobile Internet platform service software into the regulatory category, and fully considers the current and long -term network format characteristics and needs. At the same time, the "Measures" clarify the obligation of third -party platform operators of drug network trading services, including building its own quality system and fulfilling the management obligations of the platform. These obligations are the key points that regulators must grasp the regulatory authorities. Holding the main responsibility of the third -party platform operator to implement this "bull nose", it can play a role in standardizing the sales of drug networks.

>> Highlight qualification review and inspection and monitoring, strengthen platform governance

To strengthen platform governance, in addition to daily supervision of the two types of drug network sales enterprises and third -party platform operators, the third -party platform also needs to actively carry out strict qualification review and inspection and monitoring of the network operators on the platform. The first "fence" of the main role of the platform. In response to some third -party platforms when introducing merchants, there is a situation of "connecting and regardless of" and "even if", the "Measures" requires the third -party platform to review the qualifications and quality and safety guarantee capabilities of the drug network sales enterprise applied to settle in and register Archives, through the signing of the agreement to clarify the quality and safety responsibilities of both parties, and do a good job of the platform management. At the same time, the "Measures" clarify the qualification review work at least once every six months, and establish an inspection and monitoring system for the drug network sales activities on the platform. Management and disposal in the middle and after -to -the -after and after -to -the -behind. In the pre -review of the management, the "Measures" urged the third -party platform to establish a comprehensive management mechanism to be a "inspector" and "goalkeeper".

Risk management and control concrete

Close to supervision needs

Online sales varieties, prescription drug network sales, online sales drug distribution, etc. are the focus of drug network sales supervision, and it is also the focus of industry and society. On the one hand, from the beginning of ensuring the availability, the development of Internet medicine has greatly met the public's demand for pharmaceutical services. Especially during the new crown pneumonia's epidemic, online purchase of drugs has become an important way for the public to seek medical treatment; on the other hand In terms of safety perspective, the cross -regional characteristics of online purchase of drugs are obvious and there are hidden dangers of safety risks. The "Measures" considers demand and risks, strengthen quality control requirements for key issues, and provide space for the healthy development of the industry while ensuring the operability of supervision.

>> Clarify the negative list, the management of the implementation directory management of the online forbidden sale varieties

Article 61 of the "Pharmaceutical Management Law of the People's Republic of China" stipulates that vaccines, blood products, anesthesia drugs, psychotropic drugs, medical drugs, radioactive drugs, drugs and vulnerable chemicals and other countries implement special management of special management. Drugs must not be sold on the Internet. In this regard, the "Measures" fully considered the overall environment where my country's public drug safety cognitive level is not high as a whole, the Internet diagnosis and treatment have just started, and the risk of transaction risks is easily enlarged. Pharmaceuticals such as toxic drugs, radioactive drugs, and pharmaceuticals and vulnerable chemicals shall not be sold on the Internet. The specific directory shall be formulated by the State Drug Administration. " Directory management methods, on the basis of the restrictions of pharmaceutical retail entity operations, further restrict the variety of disadvantages and personal use of high -risk varieties, and also leave sufficient space for scientific supervision and dynamic adjustment. >> Strict control of prescription medicines, strengthen online sales information management and prescription management

Prescription drugs are based on prescription sales are the basic requirements of pharmaceutical retail classification management. How to obtain legal and effective prescriptions on online sales, and how to obtain prescriptions before the actual sales of drugs is the key point of supervision. The management of the "Measures" for the sale of prescription drugs is mainly reflected in the process control and information display. In terms of process control, the "Measures" requires that through the Internet, those who use the Internet for personal sales prescriptions shall ensure that the source of the prescription is true and reliable, and the real -name system shall be implemented. This provision has a ban on non -standard behaviors such as online purchase prescription medicines and re -supplementary supplements. In terms of information display, on the basis of the transparent price information and ensuring the public selection right, the "Measures" requires that "prescription medicines must be purchased and used under the guidance of pharmacists under the guidance of pharmacists" such as "prescription medicines must be based on prescriptions" under each prescription drug display page. For Those who have not passed the prescription review shall not display information such as drug packaging. These specific requirements give the foothold of the category and supervision of prescription drugs and over -the -counter drugs in the field of network sales, so that regulators can judge the standardization of corporate behavior through the "see information and review process".

>> Improve the delivery requirements and form an effective supplement with the supporting system

Regulatory practice shows that the current GSP transportation requirements are more suitable for B2B business models. If the relevant provisions are copied to carry out online drug distribution supervision, it will cause invalid supervision and waste of administrative resources. For the distribution model of pharmaceutical network retail, the industry has different views: on the one hand, the short -distance O2O model of "online store delivery and online booking stores" is less risky; on the other hand, the B2C model of long -distance cross -regional delivery can be Make up the gap between the area of ​​the area. The "Measures" starts from the needs of the convenience of public medication, and has not made absolute restrictions on distance, time, and transportation tools, but it is required to place medicines in an independent space and have obvious logos to ensure that the entire process can be traced. At the same time, the specific distribution requirements of pharmaceutical network retail are formulated separately by the national drug regulatory authorities. This system design provides a suitable standard for supervision on the basis of fully considering the status of the logistics industry, which is conducive to guiding the special characteristics of the drug industry to pay attention to the special characteristics of the drug. , Cultivate professional logistics.

Long -term work mechanism

Realize the supervision of full chain

Clear responsibilities, promote the type of main body types of integrated supervision and drug networks, the risks of different types of subjects are different, and there are differences in management methods. The "Measures" proceed from the actual situation of supervision and stipulates that the drug supervision departments at all levels shall supervise the drug network sales behavior according to their powers. examine. According to the "Measures", in accordance with the principle of territorial supervision, third -party platforms are regulated by the provincial pharmaceutical supervision department of the local registered location of the enterprise. Supervision. This not only reflects the classification of supervision ideas, but also unifies the supervision responsibilities of physical enterprises to ensure that online and offline integration supervision and improvement of regulatory efficiency.

>> Comprehensive policies to promote the formation of closed -loop supervision

Considering the characteristics of "based on entity and support information", for the supervision of drug network sales, in addition to the specifications of conventional methods such as on -site inspection and online drug sampling inspection, the "Measures" also proposed to strengthen the monitoring of drug network sales to fully reflect the fully reflect The technical support and the supervision of the network management network. On the one hand, the "Measures" proposes that the provincial network monitoring platform should be connected with the data of the national monitoring platform to reflect the integrated management of monitoring that is consistent with the network sales characteristics; on the other hand, the drug supervision department is required Investigation and disposal, emphasizing the clue value and the effectiveness of the monitoring work. The "Measures" also clearly states that the technical monitoring records can be used as an administrative penalty or adopted electronic data evidence of administrative measures in accordance with the law to provide a basis for the effective connection of monitoring work and law enforcement cases.

>> Strengthen supervision and implement the "four strictest" requirements

In order to ensure the effective supervision of science, the Measures clarify the legal responsibility of the relevant illegal situation. For example, the prohibition of pharmaceutical network sales companies includes: not reporting information to the regulatory authorities in accordance with regulations, displaying drug information illegally, existing prescriptions and prescriptions for first -first drugs, regulations that violate the real -name purchase of prescription drugs, and the true and reliable measures of the non -executed guarantee prescription source, and the true and reliable measures of the source of the prescription, and the source of the prescription source, and the true and reliable measures of the source of the prescription, and the true and reliable measures of the source of the prescription, and the true and reliable measures, and the true and reliable measures of the source of the prescription. Violation of relevant regulations of GSP. For another example, the prohibition of third -party platforms includes: failing to record to the regulatory authorities in accordance with regulations, displaying drug information in violation of regulations, existing drugs and prescribed behaviors, and failure to establish drug quality and safety management institutions, systems and equipment personnel in accordance with regulations. The situation of the provision of the unit of electronic prescriptions and signing an agreement has not been implemented for the renewal obligations of the residence review and verification. Among them, the latter three categories will be responsible for the responsibility system in accordance with the punishment of the "Platform of the Pharmaceutical Management Law of the People's Republic of China" Article 131. The setting of the above -mentioned legal responsibility will effectively enhance the execution and binding power of the Measures, provide the necessary basis for grass -roots regulatory law enforcement, and effectively ensure the safety, effectiveness, and being available in public medication. (Shi Lan, Director of the Pharmaceutical Regulatory Office of the Shanghai Drug Administration)

Source: China Medical Newspaper

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