China Requires Online Drug Sellers and E-commerce Platforms to File Necessary Information

by Grace Wang Dec 14, 2022

On Nov. 31, 2022, China National Medical Products Administration (NMPA) specified the requirements for online drug sellers and online drug transaction platforms to file necessary information to local regulators.1

The information filing is required in the Administrative Measures for Supervising Online Sales of Drugs (hereafter referred to as the Measures), which took effect on Dec. 1, 2022. The Measures permits prescription drugs to be sold online in addition to OTC drugs.2

Information Reporting for Online Drug Seller Companies

Companies selling drugs online shall send necessary information as required to local drug regulators.

Drug seller company

Local drug regulator

Marketing authorization holder (MAH) or drug supplier

Local provincial-level medical products administration

Drug retailer

Local municipal-level or county-level medical products administration

The information includes

Ÿ   Type of online sales platform: whether the company sells on a self-built online platform, or a third-party platform, or both.

Ÿ   Contact person’s information;

Ÿ   The company’s name, social credit code, company type (could be one or more among MAH, manufacturer, wholesaler, and retailer);

Ÿ   Code of drug manufacturing/supplying license;

Ÿ   Code of online drug informational service license (obligatory for companies selling drugs on self-built online platform), etc.

If the company changes the information, it shall report the change to the competent authority within 10 workdays.

Record Filing for Online Drug Sales Platform Company

Third-party platforms for online drug sales shall file records to local provincial-level medical products administrations. 

The platforms shall send the filing application form and the certification documents to the relevant authority. The certification documents include:

Ÿ   The original version or a scanned copy of the application form with signature and official seal;

Ÿ   A scanned copy of the original version of the business license;

Ÿ   A scanned copy of the original version of the legal representative or the primary responsible person’s identity document;

Ÿ   Identity documents and professional certificates of the drug quality & safety management organization’s responsible person and pharmacy technicians;

Ÿ   Organizational chart and specifications;

Ÿ   A scanned copy of the telecommunications service license, and a statement about the non-business internet content provider (ICP) filing;

Ÿ   A scanned copy of the original version of the online drug informational service license;

Ÿ   A table of contents of the documents on the system managing the quality of online drug transaction services.

Ÿ   Introduction of the basic information and functions of the website and/or applications;

Ÿ   Other certification documents.

The provincial-level medical products administration will verify the documents. If the documents are complete and compliant, the administration will accept the record filing. Within 7 workdays after the platform successfully completes filing, the administration will publish part of the filed information, including:

Ÿ   Company name;

Ÿ   Legal representative;

Ÿ   Website name;

Ÿ   Application name;

Ÿ   Website’s domain;

Ÿ   Website’s IP address;

Ÿ   Telecommunications service license and non-business ICP filing code;

Ÿ   Filing code of the third-party online drug transaction platform. 

Read about other requirements for online drugs sales in China:

Grace Wang
ChemLinked Regulatory Analyst & Editor
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