# Policy and Regulation Basis

Article 15 of the Regulations on the Administration of Medical Institutions

Medical institutions must register to practice and obtain a Medical Institution Practice License.

National Drug Administration Article 3 of the Announcement of the National Health Commission on Issuing the Provisions on the Administration of Drug Clinical trial Institutions (No. 101 [2019])

The drug research and development activities and the clinical trials (including the bioequivalence trials after recordation) approved by the SFDA within the territory of the People's Republic of China shall be conducted in the drug clinical trial institutions. A drug clinical trial institution shall meet the requirements of these Provisions and be subject to recordation administration. Institutions that only perform analyses of biological specimens, etc., relevant to a clinical trial of a drug are not required to file.

# Examples of Qualifications

Certificate of public service unit legal person:

< Certificate of accreditation of drug clinical trial institutions >:

Medical Institution Practice License:

Filing of drug clinical trial institutions: