In accordance with the provisions of the "Measures for the Administration of Drug Registration", in order to clarify the principles, procedures, time limits and requirements for the implementation of drug registration verification, and standardize the connection between the on-site verification of drug registration and the inspection of pre-market drug production quality management practices, the Food and Drug Review and Inspection Center of the State Drug Administration has organized and formulated the "Drug Registration Verification Work Procedures (Trial)" (see Annex 1), "Key Points and Judgment Principles of Drug Registration Verification (Pharmacology and Toxicology Research) (Trial)". Key Points and Judgment Principles for Drug Registration Verification (Drug Clinical Trial) (Trial)" and "Key Points and Judgment Principles for Drug Registration Verification (Pharmaceutical Development and Production Site) (Trial)" (see Annex 2-4), and "Working Procedures for the Convergence of Drug Registration and Production Site Verification and Pre-market Good Manufacturing Practice Inspection (Trial)" (see Annex 5), with the consent of the State Drug Administration, are hereby promulgated and will come into force on January 1, 2022.
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