本文简要介绍我国注射剂质量和疗效一致性评价的实施背景、开展注射剂一致性评价关注的重点、一致性评价研究的主要内容,以及当前我国开展一致性评价的现状和进展情况,从专业和市场角度提出,加快注射剂质量和疗效一致性评价,对全面提升我国化学药品质量、进一步降低患者用药负担具有现实意义和长远的历史影响。
<<This report briefly introduced the implementation background of the consistency evaluation on the quality and efficacy of injections in China,the focus of the consistency evaluation of injections,the main content of the consistency evaluation research,and the status quo and progress of the consistency evaluation in China. From the professional and market perspectives,it pointed out that accelerating the consistency evaluation on the quality and efficacy of injections would bring about practical significance and long-term historical impact on comprehensively improving the quality of chemical drugs in China and further reducing the burden of patients’ medications.
<<