Thorough Investigation! The National Medical Products Administration's "Clearing the Network Action" Addresses These Behaviors

Recently, the National Medical Products Administration issued the 2020 Medical Device "Clean Network Action" work plan, requiring adherence to the principles of "online" and "offline" linkage, and the combination of information and products. It aims to strengthen the management responsibilities of third-party platforms for medical device online transactions and the main responsibilities of medical device online sales enterprises, implement the local regulatory responsibilities of drug regulatory departments, increase monitoring of medical device online transactions, and severely crack down on illegal and irregular activities.

Key investigations include: third-party platforms failing to fulfill legal obligations, not verifying the enterprises that settle in, not monitoring the sales behaviors and information of medical devices on the platform, failing to stop online transaction services and report illegal activities upon discovering violations; online sales enterprises selling unregistered or unrecorded medical device products, publishing false medical device product information, and other illegal activities; third-party platforms and online sales enterprises not cooperating with drug regulatory departments in supervision and inspection, refusing, concealing, or not truthfully providing relevant materials and data.

The plan emphasizes that drug regulatory departments at all levels must earnestly implement the requirements of "the four strictest" and increase the crackdown on illegal and irregular activities. For "online" false information, thorough investigations must be conducted, and no leniency will be tolerated.

>> The National Medical Products Administration fully deploys special rectification.

"Online drug sales, as an emerging business model, must adhere to the principles of lawful operation and 'consistency between online and offline'. The bottom line of quality and safety cannot be breached, and a fair and orderly market environment cannot be disrupted." It is worth noting that this is the first comprehensive deployment by the National Medical Products Administration for the special rectification of illegal and irregular online sales of drugs and medical devices after the implementation of the new "Drug Administration Law."

The newly revised "Drug Administration Law" clearly states that online sales of drugs must comply with the relevant provisions of the "Drug Administration Law" regarding drug operations, which includes restrictions on special management drugs. It stipulates that drugs subject to special management by the state, such as vaccines, blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, and radioactive drugs, cannot be sold online. It also defines the responsibilities of third-party platform providers for drug online transactions.

The new law emphasizes that "online and offline must be consistent", so for the entities selling drugs online, they must first be licensed physical enterprises, meaning they must have a license offline before they can sell drugs online. Additionally, online drug sales must comply with the new drug administration law regarding retail operations. Considering the particularity of online sales, stricter requirements are set for prescription drugs sold online, such as the drug sales network must be interconnected with the information systems of medical institutions to ensure information sharing, mainly to ensure the authenticity of prescription sources and safeguard patient medication safety. At the same time, delivery must also comply with the requirements of drug operation quality standards.

The special action clarifies three major rectification points:

First, focus on cracking down on "overseas purchasing miracle drugs", "folk remedies", unlicensed products and unqualified operators, severely investigate illegal online sales of vaccines, blood products, narcotic drugs, and drug-related precursors, standardize online prescription drug sales, eliminate risk hazards, and guide the healthy development of the industry.

Second, ensure task implementation. Provincial drug regulatory departments must promptly formulate rectification plans, refine and decompose tasks, strengthen policy promotion, and enhance industry self-discipline; at the same time, strengthen clue investigation and case handling, concentrating superior forces on important clues such as the production and sale of counterfeit drugs, resolutely investigate thoroughly, impose severe penalties according to law, and ensure that penalties are strictly enforced.

Third, innovate regulatory methods, explore information-based regulatory means, urge the implementation of third-party platform management responsibilities, and achieve "internet management of the internet"; at the same time, use big data analysis technology, leverage drug traceability information and online transaction trace information to enhance the targeting and specificity of regulation, achieving "online and offline integrated regulation". A regulatory system compatible with the new regulatory system should be established, and inter-departmental cooperation should be strengthened to form a collaborative management work pattern.

>> Eight key rectification points clarified, severely crack down on illegal and irregular activities.

Currently, there are some prominent issues in online drug sales, including unqualified entities illegally selling drugs, irregular sales of prescription drugs, non-drugs posing as drugs, inadequate pharmaceutical services, and potential risks in the delivery process. At the same time, the virtuality, concealment, and cross-regional characteristics of online drug sales also make evidence collection and punishment difficult.

Drug regulatory departments should provide normative guidance and severely crack down on illegal and irregular activities. As of now, provinces including Shandong, Liaoning, and Anhui have issued relevant notices to carry out special rectification of online drug sales. 21st Century Pharmacy has summarized the following major rectification points.

Eight key rectification points for online drug sales.

This special action focuses on rectifying the following illegal and irregular activities:

(1) Selling counterfeit or inferior drugs online;

(2) Engaging in online drug sales without obtaining drug production and operation qualifications;

(3) Selling drugs subject to special management by the state online, such as vaccines, blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, and drug-related precursors;

(4) Selling drugs online without obtaining drug approval documents;

(5) Selling medical institution preparations online in violation of regulations;

(6) Selling prescription drugs without conducting prescription review and dispensing as required;

(7) Third-party platforms failing to strictly fulfill qualification review obligations and inadequately managing drug operation behaviors occurring on the platform;

(8) Providing online drug information services without possessing the "Internet Drug Information Service Qualification Certificate".

The Liaoning Drug Administration requires that online drug sales enterprises must report their enterprise name, self-built website name, URL (for those settled on third-party platforms, provide platform name, URL, as well as store name and URL), internet drug information service qualification certificate number, and the directory of online sold drug varieties, along with relevant supporting materials, to the drug regulatory department; drug retail chain headquarters must also report the online drug sales situation of their affiliated stores. For online sales of prescription drugs, they must also report the registration information of the licensed pharmacists responsible for prescription review. Any changes in relevant information must be promptly updated.

Drug marketing authorization holders, drug manufacturing enterprises, wholesale enterprises, and drug retail chain headquarters must report to the provincial drug regulatory bureau's inspection department; drug retail chain store and individual pharmacies must report to the municipal bureaus. Third-party platforms must report their business licenses, website names or network client application names, website URLs, and internet drug information service qualification certificate numbers to the provincial drug regulatory bureau's drug circulation supervision department.

Municipal bureaus and provincial drug regulatory bureau's inspection departments must quickly ascertain the current situation of enterprises engaged in online drug sales activities within their jurisdiction and urge drug manufacturing and operating enterprises that have already engaged in online drug sales activities to complete reporting as required, establishing a daily supervision ledger; at the same time, they should ensure that new enterprises engaging in online drug sales activities complete the reporting work.

Strengthen the supervision of online sales of prescription drugs by retail pharmaceutical enterprises, urging companies to implement prescription review systems, especially for retail chain headquarters. They should be urged to enhance the control of prescription drug sales online at their affiliated stores and fulfill management responsibilities. For enterprises or units with issues or hidden dangers identified during inspections, a detailed list should be compiled, urging companies to rectify within a specified time frame, ensuring that each issue is addressed and resolved, and that enforcement and rectification are effectively carried out.