Abstract: The multi-component biochemical drugs are listed in the national key monitoring drugs catalogue because of their complex sources, unknown material basis and high adverse reactions in clinical application of some varieties.Although the adverse reactions are mostly related to anaphylactic reactions, at present, there are few studies on the anaphylaxis of multi- component biochemical drugs, and a complete evaluation system of anaphylactic research has not been formed.Therefore, based on the analysis of the characteristics of multi-component biochemical drugs and the related literature on the allergy research of complex mechanism drugs at home and abroad in recent years, this paper expounds the allergy and pseudoallergy evaluation strategies applicable to multi-component biochemical drugs, and analyzes and summarizes the means and technical methods of allergy research from both in vivo and in vitro, with a view to the clinical application and safety of multi-component biochemical drugs research and production process optimization to provide reference and basis.