In order to strengthen the supervision and management of drug clinical trial institutions, in accordance with the requirements of the Drug Administration Law, Drug Registration Management Measures, Drug Clinical Trial Institution Management Regulations, and Drug Clinical Trial Quality Management Standards, the Food and Drug Audit and Inspection Center of the National Medical Products Administration has drafted the "Key Points and Determination Principles for Supervision and Inspection of Drug Clinical Trial Institutions (Draft for Comments)" (Attachment 1), We are now soliciting opinions from the public. Please send the feedback form (Attachment 2) to your email address before August 2, 2023 ningj@cfdi.org.cn Please indicate the subject of the email as "Feedback on Key Points for Supervision and Inspection of Drug Clinical Trial Institutions and Determination Principles".

In order to further standardize the supervision and inspection work of drug clinical trial institutions and strengthen the management of drug clinical trials, the National Medical Products Administration has organized the drafting of the "Measures for Supervision and Inspection of Drug Clinical Trial Institutions (Trial) (Draft for Comments)" (Attachment 1), which is now open for comments.

Please fill out the feedback form (Attachment 3) and provide feedback to the email address before August 2, 2023: ctisxsd@nmpa.gov.cn Please indicate "Feedback on the Supervision and Inspection Measures of Drug Clinical Trial Institutions" in the email subject.