1. Scope

This Procedure specifies the principles for classifying information shared between the National Medical Products Administration (NMPA) and other regulatory agencies, as well as the working procedures for such sharing.

2. Referenced Documents

2.1 Regulations of the People's Republic of China on Open Government Information

2.2 Guidelines of the National Medical Products Administration on Open Government Information

3. Terms and Definitions

3.1 Requesting Regulatory Agency

A relevant regulatory agency that requests information sharing with the NMPA for regulatory work purposes.

3.2 Information Generating and Holding Department

The department that, by virtue of its regulatory responsibilities, owns and maintains relevant regulatory information, and is responsible for providing such information or formulating a response under this procedure.

4. Working Procedures and Requirements

4.1 Public Information

Information already available on the English website could be directly accessed by the requesting regulatory agency. Information not available on the English website shall be compiled and collected by the NMPA before being provided externally.

4.2 Non-Public Information

The requesting regulatory agency and the NMPA shall, in accordance with their respective laws and regulations, agree on the scope of information to be shared and sign a confidentiality agreement, after which both parties shall proceed with information sharing activities.

5. Contact Information

Email: dicbilateral@nmpa.gov.cn