Eight technical guidelines, including the "Technical Guidelines for Drug Safety Pharmacology Research" drafted by the Center for Drug Evaluation, have been approved by the State Food and Drug Administration and officially released on May 13.
The 8 technical guidelines released this time include "Technical Guidelines for Drug Safety Pharmacology Research", "Technical Guidelines for Drug Single-dose Toxicity Research", "Technical Guidelines for Drug Repeated Dosing Toxicity Research", and "Drug Non-toxicity Research Technical Guidelines". The five technical guidelines, including the Technical Guidelines for Clinical Pharmacokinetic Research and the Technical Guidelines for Drug Irritation, Allergy and Hemolysis Research, are based on the non-clinical Chinese medicines, natural medicines and chemical medicines formulated by the National Bureau in 2005. Consolidation of technical guidelines for safety studies. The newly formulated "Technical Guidelines for Drug Toxicokinetics Research", "Technical Guidelines for Nonclinical Research on Potential Effects of Drug QT Interval Prolongation" and "Q&A for Testing Requirements for Drug Nonclinical Safety Evaluation of Test Products" are based on The current international understanding of key issues in non-clinical safety evaluation of drugs is formulated in combination with the future development of drug non-clinical safety evaluation in my country.
The release of the above-mentioned guiding principles will help improve the scientificity and standardization of the non-clinical safety evaluation of drugs in my country, and lay an important foundation for further improving the guiding principle system in my country.
To understand the specific content of the 8 technical guidelines including the "Technical Guidelines for Drug Safety Pharmacology Research", please log on to the website of the State Food and Drug Administration.
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