National Medical Products Administration Center for Drug and Food Review and Inspection, Announcement on the Issuance of the "Key Points and Criteria for Supervision and Inspection of Drug Clinical Trial Institutions (Trial)" (No. 9 of 2023)
Release time:
2025-04-21
To implement the requirements of relevant regulations such as the "Pharmaceutical Administration Law of the People's Republic of China", the "Regulations on Drug Registration Administration", and the "Trial Measures for Supervision and Inspection of Drug Clinical Trial Institutions", and to strengthen the supervision and management of drug clinical trial institutions, the Center for Drug Evaluation and Inspection of the National Medical Products Administration has formulated the "Key Points and Determination Principles for Supervision and Inspection of Drug Clinical Trial Institutions (Trial)" (see attachment), which has been approved by the National Medical Products Administration and is hereby released and shall come into effect from March 1, 2024.
This is hereby announced.
Center for Drug Evaluation and Inspection, National Medical Products Administration
November 3, 2023
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