Internet drug licensing policy will be adjusted

The 26th China Pharmaceutical Industry Development Summit Forum was held in Guangzhou today. Liu Xiaoping, deputy inspector of the Department of Drugs and Cosmetics Supervision of the State Food and Drug Administration, revealed at the forum that in order to meet the requirements of the rapid development of Internet e-commerce, the supervision of food and drug network sales has been further strengthened, and the General Administration of Food and Drug Administration has launched Internet food and drug products since 2013. After more than a year of investigation and study of the adjustment of business regulatory policies, the adjustment of the Internet drug regulatory system will be issued by administrative regulations.

In reporting on the work of the State Food and Drug Administration in the construction of the legal system, Liu Xiaoping introduced the revision of the "Drug Administration", the reform of the drug registration approval system, the application of the "black list" system, the development of the flight inspection system, and the reform of the drug sampling inspection system. The enactment of production management regulations, etc., have all started to take effect. According to him, in the future, China will implement a risk classification management system for pharmaceutical production enterprises, divide the company into different risk levels, implement differentiated management, and increase the risk information analysis and judgment according to the requirements of the new situation, and plan to fix the risk information judgment as a system. , Conduct risk assessments on a regular basis and adopt appropriate regulatory measures.

In order to adapt to the rapid development of e-commerce in the Internet and further strengthen the supervision of food and drug network sales, the State Administration of Food and Drug Supervision has carried out the adjustment of Internet food and drug business regulatory policies since 2013. Liu Xiaoping stated that after more than one year of investigation and research The adjustment of Internet drug regulatory system will be issued by administrative regulations. The details are as follows:

The adjustment of Internet drug licensing policy is based on the requirements of the Party Central Committee and the State Council on the reform of the administrative examination and approval system. It also creates a favorable environment for the development of Internet drug business activities. It focuses on “focusing on risks, seizing the key points,” and “reducing the scope of examination and approval, decentralizing approvals. The "adjustment of authority" and other principles of the original adjustment made a substantial adjustment to the Internet licensing system for pharmaceuticals that has been in operation for the past decade. The regulations for the approval of Internet drug sales and information service qualification after adjustment are:

1. B2B third-party trading platforms, drug production and drug wholesale companies do not need to approve or file for online drug purchase and sales activities.

2. Pharmaceutical retailers with licensed pharmacists can engage in B2C drug sales activities after they have informed or license the sales website.

3. The B2C third-party trading platform shall be examined and approved by provincial food and drug supervision authorities according to the conditions for approval.

4. The website for the development of internet drug information service will be submitted to the provincial supervisory department for record filing. In general, except that the B2C third-party platform needs to undergo administrative examination and approval, the others only need to record the system or inform the record.

In addition, Liu Xiaoping also clearly pointed out that there are conditions for engaging in online drug sales activities.

1) Self-constructed websites selling drugs need to have a drug business license (retail), and notify the issuing authority of the website in accordance with regulations.

2) Equip with licensed pharmacists to establish an online pharmacy service system for licensed pharmacists. The licensed pharmacist will be responsible for the review of prescriptions and regulatory deployment, and will guide rational drug use. 3) It will provide online inquiry, orders, electronic contracts, and online payment services. There are also security systems that adapt to Internet sales transactions, including storage and transportation management systems.

Conditions for operating third-party trading platforms: Qualifying certificates issued by the provincial food and drug regulatory authorities; having a system for guaranteeing drug quality and safety; having online trading services such as online inquiry, order generation, electronic contract, and online payment; and having a pharmaceutical quality management agency or full-time Drug quality management personnel; to be equipped with appropriate licensed pharmacists, to guide the management of some pharmacist services and some pharmacist service activities on the online shop.

Requirements for online normative management: publicize legal qualifications on the trading page, etc.

Liu Xiaoping said that the three aspects of policy requirements need attention, sales of prescription drugs is only a limited gradual release, and may be a "positive list" to limit the scope of sales; operators of drugs sold through the Internet can be entrusted to drug wholesalers Or meet the requirements of professional logistics companies for distribution. Operators conduct product display promotion during Internet sales activities. Their contents must be limited to the scope of approved drug packages, labels, and instructions. Propaganda drugs can be displayed on the Internet sales interface and can only be limited to the statutory drug standard label instructions. Within the scope, any exaggerated propaganda is illegal. Nowadays, there are many exaggerated false propaganda on the Internet. It is absolutely not allowed afterwards and it is a violation.