ISSUING AUTHORITY:

National Medical Products Administration

DATE OF ISSUANCE:

May 30, 2025

EFFECTIVE DATE:

May 30, 2025

On May 30, 2025, the National Medical Products Administration (NMPA) issued the Regulations on the Management of Experimental Research on Anesthetic and Psychotropic Drugs (“Regulations”), which took effect on May 30, 2025. The Regulations are designed to enhance the management of experimental research on anesthetic and psychotropic drugs and to standardize the supervisory inspection of the experimental research. Comprising four chapters, the Regulations outline the responsibilities among experimental research regulatory departments at different levels, the qualifications required of experimental research applicants, the process for approvals, and the legal penalties for violating these regulations.

Firstly, NMPA defines the scope of application and eligibility requirements for experimental research.  Applicants and Joint Development Units must have the relevant qualifications and are expected to uphold disciplinary standards. This includes but is not limited to having secure storage requirements, receiving professional education, and absenting from dishonesty lists.

Secondly, the Regulations provide a comprehensive guide to the management of experimental research, which encompasses detailed regulations on the approval deadline, relevant requirements for extension applications, the process for applying to change joint development units, and other requirements related to anesthetic and psychotropic drugs experimental research. In accordance with the Regulations, a stricter approval procedure for drug experimental research licenses shall be implemented by NMPA. In addition, the Regulations encourage drug innovation guided by clinical value and with clear therapeutic effects.

Last, but not least, the Regulations stipulate the legal liabilities for violations of administrative provisions, including penalties such as revocation of approval licenses, imposition of fines, and inclusion in dishonesty lists. Operating in parallel with these Regulations, the provincial medical products administrations will play an important role in supervision and inspecting the management of experimental research within their administrative regions.

The Regulations aim to strengthen safety management and regulatory coordination in anesthetic and psychotropic drugs experimental research, and to implement stringent control over risks associated with anesthetic and psychotropic drugs. Moreover, the provincial drug administrations should enhance cooperation with public security and anti-narcotics departments, controlling active substances generated during experiments being diverted to illegal channels.

Reference:

《国家药监局关于发布麻醉药品和精神药品实验研究管理规定的公告》