我国仿制药人体生物等效性临床试验研究室建设的现状与发展路径

Current Status and Future Development of Clinical Laboratories for Bioequivalence Analysis of Generic Drugs in China

我国开展仿制药一致性评价最主要的困难之一是临床试验资源不足,解决办法是考虑将生物等效性临床试验资格认定调整为备案管理。因此,对备案的医疗机构建设生物等效性试验研究室是一个潜在的挑战。文章分析了国内当前具备生物等效性/Ⅰ期临床资质的机构、分布、承担项目能力及生物等效性临床试验机构、药物分析实验室和合同研究组织之间的关系等,对仿制药生物等效性临床试验研究室的建设内容和规模展开讨论,供业内及监管部门参考。

The shortage of resources for conducting clinical trials is one of the major obstacles in bioequivalence evaluation of generic drugs in China. To provide a solution to this problem, we suggest that the regulatory authority should apply a new registration system instead of the accreditation of clinical trial agencies. As a result, constructing bioequivalence laboratories in the registered medical institutions will become a potential challenge. This paper analyzed the agencies qualified for BE/phase I clinical trial in China, their distribution and abilities to undertake clinical projects, as well as the relationship among BE Clinical Pharmacology Unit （CPU）, Division of Samples Analysis （DSA） and Contract Research Organization （CRO）. The construction items and size of clinical laboratories for bioequivalence analysis of generic drugs were discussed, so as to provide reference for pharmaceutical industry and regulatory authorities.