I. Background for Formulating the Compliance Guidelines for Online Retail of Prescription Drugs
The CPC Central Committee and the State Council attach great importance to drug safety. A series of important arrangements have been deployed to safeguard people’s health and strengthen drug‑safety supervision, continuously improving China’s drug regulatory system for the new era, enriching the connotation of drug regulation, and providing fundamental guidelines for reform and development in drug‑regulation field. Led by the National Medical Products Administration (NMPA), the whole regulatory system has thoroughly implemented the Action for Consolidating and Elevating Drug Safety and continuously carried out the "Source Purification" Campaign for drug distribution. Focusing on key links such as online sales, authorities have continuously improved laws and regulations, strengthened supervision and inspection, optimized monitoring platforms, improved coordination mechanisms, built a pattern of co‑governance, and intensified case investigation and handling. With the strictest regulation, authorities keep standardizing the order of online drug sales and effectively guarantee people’s medication safety.
Nevertheless, findings from routine monitoring and supervision inspections reveal that some third‑party online drug‑trading platforms (hereinafter referred to as third‑party platforms) and online pharmaceutical retail enterprises still suffer from imperfect compliance‑management systems, inadequate compliance‑operation mechanisms and insufficient awareness of compliance management. In particular, illegal sales of prescription drugs still occur from time to time. It is urgent to formulate relevant documents to consolidate enterprises’ primary responsibilities and guide law‑abiding and compliant business operations. To further safeguard public safety of online drug purchases, respond to industry demands for high‑quality development, and consolidate achievements in compliance governance for online drug sales, the timely issuance of the *Compliance Guidelines for Online Retail of Prescription Drugs* (hereinafter referred to as the Guidelines) helps foster a fair, transparent and predictable institutional environment, assists enterprises in effectively preventing operational risks, and promotes sound and sustainable development of the online‑drug‑sales industry on the basis of strictly observing safety bottom lines.
II. Overall Ideas and Main Contents of the Guidelines
As normative guidance for quality management and supervision of online retail of prescription drugs, the Guidelines follow four major principles in formulation. First, adhere to law‑based governance and refine requirements. Relevant contents are developed by in‑depth research on building a compliance system for online retail of prescription drugs, in accordance with regulatory documents including the *Drug Administration Law of the People’s Republic of China*, *Regulations for Implementing the Drug Administration Law of the People’s Republic of China*, *Measures for the Supervision and Administration of Online Drug Sales*, and *Measures for the Supervision and Administration of Quality in Drug Operation and Use*. Second, adhere to problem‑orientation and focus on practical outcomes. Taking features of online sales into account, the Guidelines drive continuous standardization of online retail practices for prescription drugs from multiple dimensions including system construction and prescription‑review requirements, targeting key and difficult issues such as selling prescription drugs without valid prescriptions and inadequate prescription review. Third, prioritize key areas and consolidate responsibilities. Given the pivotal role of third‑party platforms in the whole ecosystem of online drug sales, the formulation highlights normative guidance for platform compliance management, sets clear requirements for safety assurance across all links in the whole chain of online prescription‑drug retail, and fully implements primary responsibilities of all relevant parties. Fourth, address both symptoms and root causes to pursue sound development. Emphasis is placed on building a long‑term compliance‑governance mechanism. While actively regulating platform management activities and sales practices of pharmaceutical enterprises, policy orientation for drug regulation is strengthened. Full consideration shall be given to violation risks associated with sales of overseas prescription drugs; consumers shall not be induced to take irrational medication via livestreaming. Regulatory expectations are clarified to guide orderly exploration by the industry and build a sound ecosystem for online drug sales.
Composed of four chapters and forty‑two articles, the Guidelines cover General Provisions, Compliance Requirements for Business Entities, Compliance Requirements for Business Activities, and Compliance Requirements for Third‑Party Platform Administration. Centering on key elements of online retail of prescription drugs, they assign primary responsibilities for guaranteeing quality and safety of online‑sold drugs to every procedure and link.
III. Major Features and Requirements of the Guidelines
First, requirements for the quality‑management system. As the institutional cornerstone for safe, effective and stable drugs, the quality‑management system covers all links including drug procurement, storage, sales and delivery. Establishment and implementation of such a system can effectively sustain compliance in business operations. The Guidelines require platforms to establish and improve quality‑management systems for online drug sales, standardize prescription circulation and review workflows within platforms, strictly guard against non‑compliant prescriptions, and ensure patients’ medication safety. Online pharmaceutical retail enterprises shall continuously improve their quality‑management systems, consolidate primary responsibilities, impose full‑process strict controls over drug quality, and ensure legitimate sources and full traceability.
Second, requirements for information display. Authentic, accurate and legitimate display of drug information helps consumers rationally use prescription drugs under pharmacists’ guidance and prevents erroneous purchase and application caused by incomplete information or exaggerated promotion. False or misleading information may result in inappropriate medication, severe adverse drug reactions and even life‑threatening consequences. Law‑compliant information display can effectively curb illegal acts such as unlicensed drug sales, prescription‑drug abuse and leakage of controlled medicines. Under the Guidelines, enterprise qualifications and licensed‑pharmacist credentials shall be prominently publicized. Displayed drug information shall be subject to package inserts without false content. Prominent risk warnings for prescription drugs shall be posted; Rx and OTC labels shall be clearly distinguished; warnings such as “Athlete Warning” shall be marked for stimulant‑containing medicines. Platforms shall inspect and rigorously manage activities including prescription‑drug information release, prescription review and prescription‑drug sales to guarantee authenticity, accuracy and legitimacy of prescription‑drug information displayed and listed on platforms.
Third, requirements for pharmaceutical services. Licensed pharmacists play a vital role in enterprise drug‑quality management, prescription review and dispensing, provision of rational‑medication guidance and consultation for the public, and collection and feedback of adverse‑drug‑reaction information. The Guidelines mandate online pharmaceutical retail enterprises to establish and implement online pharmaceutical‑service systems in accordance with provisions, deploy licensed pharmacists matching business scale, and properly preserve records of online pharmaceutical services. Platforms shall engage pharmaceutical‑technical personnel for drug‑quality‑management work and perform inspection and administration duties for prescription‑drug information display and business activities within platforms.
Fourth, requirements for drug‑purchase workflows. Diagnosis prior to prescription and prescription prior to drug dispensing constitute an indispensable path for tightening medication‑safety administration, elevating rational‑medication levels and safeguarding consumers’ health rights and interests. The Guidelines emphasize that platforms and online pharmaceutical retail enterprises shall comply with provisions on internet‑based medical consultation and prescription management, scientifically set workflows and interface functions for medical consultation‑driven prescription generation, prescription review and drug sales, separate drugs from prescriptions, and clearly distinguish different service providers. Platforms shall standardize internal workflows for prescription circulation and review and provide necessary medication guidance for patients.
Fifth, requirements for risk early‑warning. Moving risk controls forward is instrumental to safeguarding drug quality and safety. The Guidelines require platforms to formulate, implement and continuously improve risk‑management systems for drug quality and safety. Platforms are encouraged to build mechanisms for risk monitoring, analysis, assessment, prevention, early warning and response, and conduct inspection and monitoring over online pharmaceutical‑retail activities on platforms. It is advisable for platforms to set up online monitoring‑and‑early‑warning systems, giving priority to abnormal sales of medicines containing substances listed in stimulant catalogues, compound preparations of psychotropic drugs and other medicines prone to substance abuse. Blocking mechanisms shall be established; sales shall be suspended for one‑off purchases or repeated purchases from one single account exceeding reasonable consumption volumes. Online pharmaceutical retail enterprises shall fully inform consumers of risks and obtain consumers’ informed consent before selling prescription drugs. Consumers shall not be induced by any means to purchase medicines inconsistent with therapeutic purposes.
Sixth, requirements for drug sales to minors. To better protect physical and mental health as well as legitimate rights and interests of minors, the Guidelines stress that when reviewing prescriptions for under‑age patients, online pharmaceutical retail enterprises shall inform buyers that purchase and use of prescription drugs require guardians’ consent and guidance from qualified pharmacists. Medication‑safety risks shall be alerted; order interception shall be performed when necessary to avert hazards to minors’ personal safety and physical‑mental wellbeing.
IV. Priorities for Supervision over Online Drug Sales
Faced with new situations and tasks for online drug sales, drug regulatory authorities will follow the requirements of the "Four Strictests", adhere to "regulating internet with internet tools" and "responding rapidly to online violations", and continuously strengthen supervision over online drug sales. Key work will be carried out as follows:
First, thoroughly advance the Consolidation‑and‑Elevation Campaign of the "Source Purification" initiative for drug distribution. Focusing on prominent problems and weak links in pharmaceutical distribution, authorities will severely crack down on crimes and violations jeopardizing drug safety, effectively forestall and defuse risks and hidden dangers in drug distribution, innovate supervision mechanisms for online drug sales, empower routine regulation with digital technologies, and jointly intensify case investigation and handling. High‑efficiency supervision shall guarantee high‑level drug safety.
Second, strengthen integrated online‑offline supervision. Enterprises engaged in online sales must hold offline business licenses and operate within approved business modes and scopes. Next‑step inspections will prioritize online operators whose shipping addresses diverge from addresses specified in Drug Business Licenses. Products sold online shall be consistent with offline offerings, and illegal substitution practices shall be rigorously prevented.
Third, reinforce requirements for information display. Online pharmaceutical retailers and third‑party platforms shall continuously publicize information such as drug manufacturing or business licenses and credentials of legally deployed pharmacists or other pharmaceutical‑technical personnel at prominent positions on homepages or main business pages. Rectification campaigns will target violations including improper display of prescription drugs or prohibited medicines.
Fourth, tighten supervision over third‑party platforms. Inspections will focus on whether platforms have established drug‑quality‑management bodies, deployed qualified staff for key posts, formulated‑implemented and sustained effective quality‑management systems, strictly reviewed and managed settled merchants as required, built dynamic monitoring and risk‑prevention‑and‑control mechanisms, complied with rules for prescription‑drug information display and sales workflows, set special rules for prohibited‑list varieties and medicines susceptible to abuse, implemented interception for minor purchases or bulk repeated purchases from single accounts, timely identified, early‑warned and disposed of drug‑safety risks, maintained authentic‑accurate‑traceable data records, and curbed high‑risk practices of platform operators such as unlicensed operation and sale of unlicensed products.
Fifth, enhance cross‑department and cross‑region coordination. Communication and collaboration with competent authorities will be strengthened, a multi‑dimensional collaborative regulatory system improved, and a cross‑regional case‑assistance mechanism for online drug sales established. Procedures for case‑clue transfer, evidence preservation and mutual recognition of test results will be standardized to break geographical regulatory barriers. Rapid detection, verification and investigation will be realized for cross‑regional violations including counterfeit‑and‑substandard‑drug sales and unlicensed operation, ensuring full regulatory coverage without blind spots.