关键词: font-size:medium, ">仿制药；一致性评价；政策环境；现状

Abstract: The government has issued a series of relevant policies and regulations to improve the entry threshold and quality of my country's generic drugs， and promote the structural adjustment of the pharmaceutical industry， and the consistency evaluation of generic drugs is a key step among them. This article sorts out the relevant policies related to the consistency evaluation of generic drugs， analyzes the current status of the policy environment for the consistency evaluation of generic drugs in China from the successive introduction of the reference preparation catalog， the imbalance in the number of clinical trial institutions in various regions， and the uneven progress of policy promotion. At this stage， China′s generic drug consistency evaluation progresses， and proposes to optimize the access to reference preparations， strengthen the supervision of clinical trials， deepen the research on pharmaceutical equivalence and bioequivalence of drugs， and pay attention to the implementation of collaborative policies. Provide a reference for the development of consistency evaluation to create a better policy environment.
   

Key words: font-size:medium, ">Generic drugs； Consistency evaluation； Policy environment； Current situation