Pharmaceutical Network, April 26th, in order to implement the key tasks of post-marketing supervision of drugs in 2020, and comprehensively promote the special rectification of illegal drug sales on the Internet, on April 24, the Drug Supervision Department of the State Drug Administration presided over a meeting of illegal drug sales on the Internet. The video conference on special rectification of violations and the scheduling of drug circulation supervision work will make specific arrangements for the supervision of online drug business behavior.

Xu Shengmin, deputy director of the Department of Drug Supervision, attended the meeting, emphasizing further standardization of online drug sales and drug online transaction services, to achieve full-process and full-cycle supervision, and to strengthen public medication safety. The leaders of the Beijing Municipal Food and Drug Administration, the Zhejiang Provincial Food and Drug Administration, the Jiangsu Provincial Food and Drug Administration, the Shandong Provincial Food and Drug Administration, and the Southern Medical Economic Research Institute of the State Food and Drug Administration (referred to as "Southern Institute") attended the meeting.

Online market chaos hits hard

The virtuality, concealment, cross-region, real-time dynamics and other characteristics of the Internet have prompted the supervision of online drug business to face new problems. For unlicensed and unqualified individuals who illegally sell drugs, illegally sell counterfeit and shoddy products, and sell prescription drugs without prescriptions, regulatory authorities at all levels urgently need to adjust their thinking, innovate their practices, and give a heavy blow to the chaos in the online market. blow.

Xu Shengmin pointed out in his speech that the drug regulatory authorities have always adhered to the spirit of prudence and tolerance for online sales of pharmaceutical products. However, prudence and tolerance do not mean placing online sales outside the law. The supervision principle of "consistency between online and offline" cannot be violated. The bottom line of quality and safety cannot be broken, and the fair and orderly market environment cannot be disrupted.

Resolutely implement the "four strictest" requirements, strengthen the supervision and management of drug online sales, seriously deal with various violations of laws and regulations, and effectively ensure the safety of public medication. The system (referred to as the "monitoring system") is used to dynamically track and monitor violations of laws and regulations in online drug business.

According to the work deployment of the State Food and Drug Administration, the monitoring system has achieved monitoring coverage of computer PC-side websites, WeChat and Weibo and other social platforms that carry out online drug business activities, as well as mobile APPs, WeChat mini-programs, WeChat stores and other online mobile clients. And completed the docking with the relevant drug administrative license and business license data of the national bureau.

Since its operation, the monitoring system has mainly carried out monitoring on the following violations of laws and regulations: those who have not obtained the "Drug Business License" and engaged in online drug sales beyond the business scope and business mode; have not obtained the "Internet Drug Information Service Qualification Certificate" to conduct drug online information services; third-party platforms have not conducted qualification audits or lax checks on the settled enterprises; sold counterfeit and inferior drugs, national special management drugs, preparations of medical institutions, unregistered imported drugs, etc. through the Internet; sold prescription drugs without prescriptions, etc.

Zong Yungang, deputy director of the Southern Research Institute, reported on the network monitoring work carried out since the launch of the national drug network transaction monitoring system. . The city bureau is linked at three levels, horizontally realizes the transfer, disposal and circulation of cross-regional clue information between provincial bureaus, and implements closed-loop traceability management of online sales supervision.

Up to now, the monitoring system has realized the daily monitoring of more than 15,000 websites in China, and collected more than 46 million times of product page information; a total of 15 issues of "Monthly Report on Monitoring of Drug Online Transactions" have been reported to timely reflect the problems existing in online drug transactions. with risk.

Xu Shengmin further demanded that all provincial drug regulatory authorities should conscientiously implement the reform of "delegating power, delegating power, regulating and serving", urging enterprises to fully implement their main responsibilities, and all departments should take the initiative to carry out Internet monitoring and management, active management, active monitoring, active discovery, active disposal, and continuous efforts. Improve the technical monitoring capabilities of the drug network sales monitoring system.

"Smart Supervision" Adapts to the New Situation

With the rapid development of e-commerce in China, "online shopping" has become one of the important ways for residents to consume daily. Obtaining medicines through the Internet is favored by the public because of its convenience and speed. Especially during the COVID-19 epidemic, sales of online medical and health products surged, and pharmaceutical e-commerce platforms and enterprises responded quickly to user needs to ensure market supply.

In fact, the sales of medicines are directly related to the vital interests of the public and to social stability. Adhering to the principle of "consistency between online and offline", always implementing "bottom-line thinking", and doing a good job in the supervision of drug operation are essential for maintaining the safety of the pharmaceutical market and safeguarding public health. Rights and interests are of great significance and play an active role in the smooth advancement of the reform of the medical and health system and the reform of the drug distribution system.

Gao Bingyang, director of the Drug Circulation Supervision Division of the Beijing Municipal Food and Drug Administration, and Chu Ruixiang, director of the Drug Circulation Supervision Division of the Zhejiang Provincial Drug Administration, said when introducing the supervision of drug online sales, since the monitoring system was launched, local regulatory authorities have actively implemented territorial supervision. Responsibility, strengthen pre-event, in-event and post-event supervision, closely monitor and severely investigate and deal with violations of laws and regulations, quickly take action on suspected violations of laws and regulations, organize interviews with platforms and enterprises, conduct on-site inspections of enterprises with illegal business behaviors, and supervise the implementation of the main body of enterprises. responsibility.

In the aspect of circulation and use, Yao Zhihong, director of the Pharmaceutical Equipment Business Supervision Department of Jiangsu Provincial Food and Drug Administration, and Lin Bingyong, director of the Drug Market Supervision Department of Shandong Provincial Food and Drug Administration, respectively reported on the supervision of drugs and vaccines. Due to the characteristics of the industry with many supervision objects, local supervision has effectively strengthened specific measures, conducted in-depth research and judgment on risks, formed work synergies, closed-loop supervision, built a normalized mechanism of "catching early and small", and continuously improved the supervision system.

According to the policy requirements of the "Drug Administration Law": third-party platform providers for online drug transactions shall, in accordance with the provisions of the drug regulatory department of the State Council, file with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located; third-party platform providers shall Review the qualifications of drug marketing license holders and drug dealers who apply to enter the platform to ensure that they meet the statutory requirements, and manage the drug dealer behavior that occurs on the platform; third-party platform providers discover drugs that enter the platform. Marketing license holders and drug distributors that violate the provisions of this Law shall promptly stop and report to the drug regulatory department of the people's government at the county level where they are located; if serious violations are found, they shall immediately stop providing online trading platform services.

It is not difficult to see that the continuous promotion of industrial chain collaboration and the formation of a new regulatory situation of social co-governance is not only a corporate responsibility, but also a social and political responsibility. Representatives of Alibaba Health and JD Group expressed their opinions on the spot, strictly abide by national and local laws and regulations, actively implement the main responsibility of enterprises, purify the ecological governance of third-party platforms, and ensure that platform companies operate in compliance with laws and regulations.

Xu Shengmin emphasized that the risk of violations and violations of drug business and circulation is high, and there are many aspects. "Smart supervision" is an effective means to ensure the quality and safety of drugs; the supervision work in the new era must always maintain a high-pressure situation, focusing on the key subjects, key areas, and key areas of online drug business. Focus on key varieties and key requirements, continuously improve the political position, firmly establish the "people-centered" supervision concept, adhere to the "nationwide game of chess", and adapt to the new situation and new needs from system design and supervision practice.

Entrusted by the Drug Supervision Department of the former State Administration, the Southern Institute started the construction of the national online drug sales monitoring system in December 2017, and completed the acceptance in November 2018. According to the requirements, the Southern Institute will closely cooperate with the National Bureau and the provincial bureaus to carry out the supervision and management of drug network sales, while using, building and improving, continuously optimizing the technical monitoring capabilities, and making every effort to provide monitoring clues, analysis, judgment and information for the National Bureau and the provincial bureaus. System technical support.