New regulations on online sales of drugs clarify the management of online sales of prescription drugs

Recently, the State Administration for Market Regulation issued the Measures for the Supervision and Administration of Online Drug Sales (Order of the State Administration for Market Regulation No. 58), which will come into force on December 1, 2022.

The CPC Central Committee and the State Council attach great importance to the responsibility of drug safety, which concerns people's lives and health. To implement the party central committee and state council on drug regulatory "four most strict requirements and a series of policy decisions, refinement, with the pharmaceutical administration law of the provisions of the drug sales network as a whole the convenience to buy medicine and drug safety supervision, to ensure the public safety and legitimate rights and interests, market supervision administration, food and drug administration on the basis of in-depth study, completely demonstrated, Measures for the Supervision and Administration of Online Drug Sales have been formulated. The Measures, consisting of six chapters and 42 articles, stipulate the management of online drug sales, platform responsibility fulfillment, supervision and inspection measures, and legal liabilities. Major articles included:

First, the principal responsibility of drug distributors should be enforced..The qualifications and requirements of drug distributors engaged in online drug sales shall be clarified, and drugs under the special administration of the State, such as vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and pharmaceutical precursor chemicals, shall not be sold online..At the same time, the whole process of drug operation management should be strictly implemented, and clear requirements should be put forward for the whole process management of online drug sales enterprises, such as quality and safety management system, pharmaceutical care, drug storage and distribution, drug traceability, risk control and information disclosure.

The second is the responsibility of online sales platforms for condensed pharmaceuticals. Clear the third-party platform should be establish drug quality and safety management agencies, with pharmaceutical technical personnel, establish and implement quality and safety of drugs, pharmaceutical information display, prescription audit, prescription medication real-name, drug delivery, transaction records, adverse reaction reports and complaints to report, management system, and in accordance with the provisions, for the record. At the same time, the platform and network sales enterprises signed an agreement, both the quality and safety responsibility precisely, platform shall perform the audit, inspection monitoring and stop service and report found serious violations of the obligations, and strengthen the platform in drug recall, emergency disposal and the supervision and inspection of the obligation.

Third, clear management of online sales of prescription drugs..Considering the medication safety risks and the online and offline consistency management requirements, the real name system for online prescription drug sales should be precisely implemented, and prescriptions should be reviewed and allocated according to regulations..Prescription and over-the-counter drugs should be displayed separately, and it should be made clear that packaging, labels and additional information should not be displayed directly on the front page and home page where prescription drugs are sold;; before passing the prescription review, no information such as instructions shall be displayed, and no services related to prescription drug purchase shall be provided, aiming to emphasize the management requirements of "prescription before medicine" and prescription review. At the same time, consumers should be thoroughly informed of relevant risk warning information and confirmed by consumers before prescription drugs are sold to effectively prevent drug safety risks.

Fourth, implement the "four strictest" requirements and strengthen the supervision measures of regulatory departments at all levels. It clarifies the responsibility division of drug regulatory departments at all levels in the supervision of online drug sales and the jurisdiction to investigate and deal with illegal acts, requires strengthening the monitoring of online drug sales, and investigates and handles illegal acts found by monitoring according to law and duties. To strengthen the control of drug safety risks, if there is evidence that there may be hidden safety risks, it is clear in accordance with the law that drug regulatory authorities can take measures such as warning, interview, rectification within a specified time limit, and suspension of production, sale, use and import. In addition, the Measures clarify the corresponding legal liability for illegal online drug sales.