Boots fall!The regulatory measures for drug network sales will be implemented from December 1st, and how much impact will it affect the third -party platform?

The 21st Century Business Herald reporter Zhu Ping Beijing reported that with the rapid development of my country's e -commerce, online shopping has become a normal consumption method, and drug network sales activities are becoming more active. In order to improve the level of medical and health modernization services, the State Council has introduced a series of policies to require innovative service models to improve the "Internet+" pharmaceutical supply guarantee services, and meet the people's growing medical and health needs.

On September 1, the State Administration of Market Supervision issued the "Measures for the Supervision and Administration of Drug Network Sales" (Order No. 58 of the State Administration of Market Supervision and Administration) (hereinafter referred to as the Measures) and implemented it from December 1, 2022.

The State Administration of Market Supervision has pointed out that in order to implement the "four most stringent" requirements and a series of decision -making arrangements on the "four strictest" requirements of the Party Central Committee and the State Council, the detailed and chemical drug management law on drug network sales, co -ordination of the convenience and convenience and convenience of the masses to purchase drugs and the convenience and convenience of drug purchase Drug safety supervision, effectively protecting the safety and legitimate rights and interests of public medication. The State Administration of Market Supervision and the Drug Administration formulated the "Measures" on the basis of in -depth research and fully demonstration. The Measures have a total of 62 chapters, which have stipulated the drug network sales management, platform responsibility performance, supervision and inspection measures and legal responsibilities.

At the same time, the State Drug Administration also released the policy interpretation of the "Measures for the Supervision and Administration of Drug Network Sales" on the official website on September 1.

Regarding the management of third -party platforms that the outside world cares about, the above -mentioned policy interpretation pointed out that third -party platforms as "platform managers" play a unique role in pharmaceutical network sales activities, which is a key part of the healthy development of drug network sales. The main body of the platform and strengthening the internal management of the platform is essential for the standardization of pharmaceutical network sales activities and the orderly development of the market. The Measures have made a series of regulations on the management of third -party platforms. If the platform shall establish a pharmaceutical quality and safety management institution, establish and implement management systems such as drug quality and safety, and equip pharmaceutical technical personnel, and will record the provincial drug supervision and management department of the local area in accordance with regulations. Inspection should be strengthened to manage the drug information display, prescription review, pharmaceutical sales and distribution of pharmaceutical network sales enterprises on the platform, and urge them to strictly fulfill their legal obligations.

In this regard, a number of Internet platform companies told the 21st Century Business Herald that the introduction of the "Measures" will be more conducive to the standardized development of the industry. Among them, the relevant person in charge of Ali Health pointed out to the 21st Century Business Herald that for many years, pharmaceutical e -commerce as a strong supplement to traditional retail has played a positive role in promoting the inclusiveness of drugs. The "Measures" further reflects the encouragement and support of the regulatory authorities for the healthy development of pharmaceutical e -commerce. At the same time, it also provides a more clear compliance guidance and requirements for the drug Internet sales, which is of great significance to the development of the industry.

Clarify the responsibility to delineate the red line

The "Measures" requires the implementation of the main responsibility of the drug business enterprise, clarify the qualifications and requirements of the drug operating enterprise sales of drug network sales, and clarify the vaccine, blood products, anesthesia drugs, psychotropic drugs, medical drugs, radioactive drugs, and pharmaceutical categories. Drugs that are specially managed by countries such as toxic chemicals shall not be sold on the Internet. At the same time, strict management of drug operations, and put forward clear requirements for the management system of drug network sales enterprises, pharmaceutical services, pharmaceutical storage and distribution, pharmaceutical traceability, risk control, and information disclosure of drug network sales enterprises.

It also requires the responsibility of compacting the drug network sales platform. Clarify that third -party platforms should set up drug quality and safety management institutions, equipped with pharmacy and technical personnel, and establish and implement drug quality and safety, pharmaceutical information display, prescription review, prescription drug real -name purchase, drug distribution, transaction record preservation, adverse reaction report, complaint report processing, etc. Management system and record in accordance with regulations. At the same time, the platform is required to sign an agreement with the drug network sales enterprise to clarify the responsibility of drug quality and safety between the two parties. It stipulates that the platform shall perform the obligations and reports of the stop service and report of the suspension of the audit, inspection and monitoring, and the discovery of serious violations. Emergency treatment and coordination obligations in supervision and inspection.

It has also made clear sales management regulations for online sales prescription medicines with a high degree of attention. Considering the safety risks of medication and online consistency management requirements, clearly implement a real -name system for the sales of prescription drug networks, and conduct prescription review and deployment in accordance with regulations. Display packaging, labels and other information; before the prescription review, no information such as instructions shall be displayed, and the relevant services of prescription medicine purchase shall not be provided. It is intended to emphasize the management requirements of "first medicine" and prescription review. At the same time, before the sales of prescription drugs, consumers should fully inform consumers to fully inform the relevant risk warning information and confirm their knowledge by consumers, and effectively prevent the safety risk of medication.

The "Measures" also implements the "four strictests" requirements to strengthen supervision measures from regulatory departments at all levels. In order to strengthen the supervision of the drug network sales and clarify the division of supervision of the rights, the "Measures" refine the supervision of the drug regulatory department in the drug network sales link on the basis of adhering to the principles of territorial supervision. The confidentiality obligations are clear and responsible, and ensure that the supervision of drug network sales is implemented.

The division of management at all levels is as follows: The supervision and management of the national pharmaceutical network sales of the State Drug Administration.

The provincial drug supervision and management department is responsible for the supervision and management of drug network sales in the administrative region, and is responsible for supervising and managing the third -party platform of the drug network transaction and the activities of the drug listing license holder and the drug wholesale enterprise to sell drugs through the network. The municipal and county -level departments of the district -level and county levels are responsible for the supervision and management of drug network sales in the administrative region, and the activities of supervising and managing drug retail enterprises to sell drugs through the network.

At the same time, the "Measures" also strengthens the control of drug safety risk. If there may be hidden safety hazards in the evidence, it is clear that the drug regulatory authorities can adopt warning, interviews, rectification within a time limit, and suspending production, sales, use, and imports.

Emphasize offline entities, professionalism, compliance

It can be seen from the "Measures" that the regulatory authorities have clearly required drug business enterprises engaged in drug network sales.

The "Measures" requires that pharmaceutical network sales enterprises must be offline physical pharmaceutical companies. If they are engaged in drug network sales, they should be a drug listing license holder or drug operating enterprise that guarantees the safety capacity of online sales, that is, the drug listing license holder Or the business enterprise obtained by obtaining a drug business license can carry out the drug network sales business.

Among them, the "Measures" made a series of regulations on the management of third -party platforms. The platform shall establish a pharmaceutical quality and safety management institution, establish and implement management systems such as drug quality and safety. It is equipped with pharmacy and technical personnel to record the provincial pharmaceutical supervision and management department in accordance with regulations. Inspection should be strengthened to manage the drug information display, prescription review, pharmaceutical sales and distribution of pharmaceutical network sales enterprises on the platform, and urge them to strictly fulfill their legal obligations. Those who do not have serious illegal acts such as qualification sales drugs should immediately stop providing online trading platform services and stop displaying information related to drugs.

From the perspective of the industry, this pair of large platforms are favorable. At present, companies including Ali Health and Dingdang Express are actually online physical pharmaceutical companies, and they all have their own pharmacy and technicians.

In addition, the "Measures" clarified the supervision of the online sales prescription drugs that the outside world has always paid attention to. The relevant person in charge of the Medical Federation pointed out to the 21st Century Business Herald that the sales of prescription drug network have been clearly prohibited, open exploration and orderly liberalization. On the whole, with the surge in the demand for remote consultation and online drug purchase, prescription drug network sales are gradually loosen in the new environment. The clear and refined regulatory requirements provide paths for industry development and construction, and also facilitate the promotion of benign development.

In response, the relevant person in charge of Ali Health also told the 21st Century Business Herald that this time the "Measures" further clarified that the prescription drug purchase related services were not allowed before the prescription audit passed. This requirement is more detailed and more operable, and the company's subsequent landing standards are more clear. "Ali Health has always adhered to the principle of purchasing medicines, continuously increasing technical and operational investment, strictly controlling the safety of medication, and continuous efforts on the premise of ensuring the safety of medication to continuously optimize the consumer's drug purchase experience."

Earlier, there have been rumors that pharmaceutical network retail companies have not been allowed to display prescription information. But from this "Measures", there are different specific requirements for related display, not directly not allowed to display.

Article 13 of the "Measures" stipulates that pharmaceutical network retail companies engaged in prescription drug sales shall highlight risk warning information such as "prescription drugs must be purchased and used under the guidance of pharmacists" under each drug display page. Before the preparation of prescription drugs, it shall fully inform consumers to tell the relevant risk warning information and confirm the knowledge by consumers.

Pharmaceutical network retail enterprises should distinguish prescription drugs from non -prescription drugs, and significantly indicate prescription drugs and non -prescription drugs on the related webpages.

Pharmaceutical network retail companies shall not directly display information such as prescription drug packaging, labels and other information on the homepage of prescription drug sales. Before the prescription review, no information such as the manual shall be displayed, and the relevant services of the prescription medicine purchase shall not be provided.

The above provisions means that they must be "first -time and then medicine", which is related to the relevant provisions of the "Internet Diagnosis and Treatment Regulatory Regulatory Detailed Rules (Trial)".

In addition, the virtuality and cross -regional characteristics of pharmaceutical network sales have brought new challenges to supervision and management, law enforcement jurisdiction, investigation of cases, and evidence.

How to strengthen the monitoring of drug network sales? The "Measures" states that the drug supervision and management department shall strengthen the monitoring of drug network sales. The drug network sales monitoring platform established by the provincial pharmaceutical supervision and management department shall achieve data docking with the national pharmaceutical network sales monitoring platform. The drug supervision and management department shall investigate and dispose of the illegal acts found in accordance with the law.

In order to adapt to new situations and solve new problems, the State Drug Administration will adhere to the "network management network", use the outstanding advantages of technical means in ensuring the quality and safety of drugs, make full use of the drug network sales monitoring platform, and continue to increase the drug network sales activities Monitoring, if you find illegal violations, will be investigated and punished in accordance with laws and regulations.

- END -