Guidelines for evaluation of clinical safety literature of listed drugs issued by SFDA

On June 18, the State Food and Drug Administration issued a circular on the guiding principles for clinical safety literature evaluation of listed drugs (Trial) The guiding principles of this release draw on the concepts and methods of evidence-based medicine classification, classification, strict evaluation and continuous updating, refer to the indicators and forms of comprehensive evaluation of health technology, and introduce the standardized operation of Cochrane system evaluation The purpose of this paper is to provide guidance for the holders of drug marketing license (hereinafter referred to as the holders) to carry out the clinical safety literature evaluation of listed drugs (including traditional Chinese medicine, chemical drugs and biological products) and write the literature evaluation report In order to further implement the main responsibility of drug safety of drug listing license holders (including manufacturers holding drug approval documents, hereinafter referred to as holders), improve the ability of holders to perform their duties, and standardize the holders' systematic evaluation of clinical safety literature, the State Drug Administration has organized and formulated the guiding principles for evaluation of clinical safety literature of listed drugs (for Trial Implementation) ）》, is hereby issued Notice is hereby given Appendix: guidelines for the evaluation of clinical safety literature of listed drugs (Trial) SFDA May 23, 2019