Asian Journal Of Social Pharmacy

Abstract: Objective To study the impact of consistency evaluation policy on pharmaceutical enterprises from four aspects: reference preparations, evaluation methods, input costs, and market competitions, and government incentives for generic drug manufacturers, so as to put forward relevant suggestions. Methods Literature research method and statistical analysis method were used to provide data support for paper writing, making suggestions, and enhancing the predictability of policy. Results and Conclusion Some pharmaceutical enterprises faced difficulties in obtaining reference preparations, high input costs for exploring evaluation methods, and greater market competition. Consistency evaluation is a key measure to comprehensively improve the quality and efficacy of generic drugs. However, difficulties in obtaining reference preparations, high input costs and complex evaluation methods all affect the enthusiasm of companies. Therefore, national and local regulatory agencies have issued some supporting policies, which should be improved to assist enterprises in conducting consistency evaluations.

Key words: generic drug, consistency evaluation, pharmaceutical enterprise, incentive policy