Policy interpretation of the Measures for the Supervision and Administration of Drug Network Sales

I.
What is the background of the formulation of the Measures for the Supervision and Administration of Drug Network Sales (hereinafter referred to as the Measures)?

 

In recent years, with the rapid development of e-commerce in China, online shopping has become a normalized mode of consumption, and drug network sales activities have become increasingly active
.
In order to improve the level of medical and health modernization services, the State Council has issued a series of policies requiring innovative service models and improving "Internet +" drug supply guarantee services to meet the growing medical and health needs
of the people.
The newly revised Drug Administration Law in 2019 and the Opinions of the General Office of the State Council on Serving the "Six Stability" and "Six Guarantees" in April 2021 to Further Improve the Work Related to the Reform of "Decentralization and Management Service" (Guo Ban Fa [2021] No.
10) all put forward work requirements
for online drug sales.

 

In order to implement the decision-making and deployment of the Party Central Committee and the State Council, implement the requirements of the Drug Administration Law, further standardize the online sales of drugs, ensure the quality and safety of drugs sold online, ensure that the people have access to drugs, and effectively protect the people's life safety and physical health, it is urgent to issue the "Measures"
.

 

SECOND, what are the main ideas formulated in the "Measures"?

 

The Measures focus on ensuring the quality and safety of drugs, facilitating the use of drugs by the masses, and improving the design of the drug network sales supervision and management system, and make provisions on the management of drug network sales, the management of third-party platforms, and the responsibilities and obligations of all parties
.

 

The "Measures" adhere to the following ideas: under the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, adhere to the people first, life first, adhere to the people-centered development thinking, and comprehensively strengthen the supervision
of drug network sales around ensuring the quality and safety of drugs, optimizing people's livelihood services, and facilitating the purchase of drugs by the masses.
First, adhere to the convenience of the people, to the people's multi-level diversified medical and health needs as the guide, relying on the advantages of Internet technology, improve the accessibility of drugs; The second is to adhere to the principle of online and offline integration, implement the main responsibility of enterprises, and guide the healthy development of the industry in accordance with laws and regulations; The third is to adhere to the network pipe network, make full use of technical means, and achieve technical empowerment and intelligent supervision; The fourth is to adhere to risk management and scientifically carry out system design with risk as the guide; The fifth is to adhere to the "four strictest" requirements and seriously investigate and deal with
violations of laws and regulations in drug network sales.

 

Iii.
What are the basic conditions that drug network sales enterprises should have?

 

The "Measures" require that drug network sales enterprises must be offline entity drug enterprises, and strengthen drug quality and safety protection and consumer rights and interests protection
.
The "Measures" stipulate that those engaged in online drug sales shall be drug marketing license holders or drug trading enterprises
that have the ability to ensure the safety of online sales of drugs.
That is, only the holder of the drug marketing license or the business enterprise that has obtained the drug business license can carry out the drug network sales business
.

 

4.
What requirements does the Measures put forward for the management of third-party platforms?

 

As a "platform manager", the third-party platform plays a unique role in the drug network sales activities and is a key part
of the healthy development of the drug network sales standard.
Compacting the main responsibility of the platform and strengthening the internal management of the platform are crucial
to the standardization of drug network sales activities and the orderly development of the market.

 

The Measures make a series of provisions on the management of third-party platforms
.
The platform shall establish a drug quality and safety management agency, establish and implement a drug quality and safety management system, allocate pharmaceutical technical personnel, and file a record
with the local provincial drug supervision and management department in accordance with regulations.
Inspections should be strengthened to manage drug information display, prescription review, drug sales and distribution of drug network sales enterprises stationed on the platform, and urge them to strictly perform their statutory obligations
.
Where it is discovered that there are serious violations such as not having the qualifications to sell drugs, the provision of online trading platform services shall be immediately stopped, and the display of drug-related information
shall be stopped.

 

V.
How to divide the authority of drug network sales supervision?

 

In order to strengthen the supervision of drug network sales and clarify the division of regulatory powers, on the basis of adhering to the principle of territorial supervision, the Measures refine the regulatory powers of drug regulatory departments in the drug network sales link, strictly enforce the confidentiality obligations of drug supervision and management departments on personal information and trade secrets, so as to achieve clear rights and responsibilities and ensure that the supervision of drug network sales is implemented
.

 

The State Food and Drug Administration is in charge of the supervision and management of the national drug network sales
.

 

Provincial drug supervision and management departments are responsible for the supervision and management of drug network sales within their respective administrative regions, and are responsible for supervising and managing third-party platforms for drug network transactions, as well as the activities of
drug marketing authorization holders and drug wholesale enterprises selling drugs through the network.

 

The departments at the districted city and county levels responsible for drug supervision and management are responsible for the supervision and management of drug network sales within their respective administrative regions, and are responsible for supervising and managing the activities
of drug retail enterprises in selling drugs through the network.

 

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How to strengthen the monitoring of drug network sales?

 

The "Measures" make it clear 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 drug supervision and management department shall achieve data docking
with the national drug network sales monitoring platform.
Drug supervision and management departments shall investigate and deal
with illegal acts discovered under monitoring in accordance with law.

 

The virtual and cross-regional nature of drug network sales bring new challenges
to supervision and management, law enforcement jurisdiction, case investigation, and evidence fixation.
In order to adapt to the new situation and solve new problems, the State Food and Drug Administration will adhere to the "network pipe network", give full play to the outstanding advantages of technical means in ensuring the quality and safety of drugs, make full use of the drug network sales monitoring platform, continue to increase the monitoring of drug network sales activities, and if violations of laws and regulations are found, they will be strictly investigated and punished
in accordance with laws and regulations.