Key Points and Judgment Principles of Supervision and Inspection of Drug Clinical Trial Institutions
2024-06-18
On November 3, the website of the Verification Center of the State Food and Drug Administration issued a notice on the key points and judgment principles of supervision and inspection of drug clinical trial institutions (for trial implementation). The full text follows.
Food and Drug Examination and Inspection Center of State Drug Administration
Announcement No. 9 of 2023 on Issuing the Key Points and Judgment Principles of Supervision and Inspection of Drug Clinical Trial Institutions (for Trial Implementation)
In order to implement the relevant requirements of the the People's Republic of China Drug Administration Law, the Measures for the Administration of Drug Registration and the Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (for Trial Implementation), and to strengthen the supervision and management of drug clinical trial institutions, the Food and Drug Examination and Inspection Center of the State Drug Administration has organized and formulated the Key Points and Judgment Principles for the Supervision and Inspection of Drug Clinical Trial Institutions (for Trial Implementation) (see annex), it is hereby promulgated and shall come into force on March 1, 2024.
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