According to the spirit of the “implementation opinion on comprehensive strengthening of the drug regulatory capacity construction” issued by the General Office of the State Council, this article aimed to provide reference for the evaluation benchmark and future direction for the improvement of drug evaluation ability under the strategy of pharmaceutical power. According to the dual organization theory, lessons were drawn from WHO and EMA competence assessment for regulatory authorities, and the drug evaluation ability model was constructed by using two rounds of expert investigation method of Delphi. The drug evaluation ability model was composed of input, process control and output modules, which contained 16 primary indicators of core competency assessment and 58 secondary indicators altogether. It will provide a basis for the assessment of the ability of drug review authority in China in the new period, to find the gap between vision and reality, to improve the ability of drug review from the long-term goal, and to promote the capability development of drug review authority.

drug evaluation  /  ability  /  ambidextrous organization  /  assessment  /  Delphi survey