FDA的关键路径动议对我国医药监管的启示

An Inspiration to Drug Administration from FDA's Critical Path Initiative in China

目的近几年来,尽管世界各国用于医药研发的投资不断增加,基础生物医学也取得了极大的进步,但是新医疗产品抵达病人的速度却越来越慢。这说明仅有更好的生物医学创见是不够的,我们还必须保证那些创见能成功地通过产品开发过程中的关键路径,最终把可靠、安全、有效的医疗产品以病人偿付得起的价格提交给病人。本文的目的即是唤起人们对于这一问题的思考。方法将美国食品药品管理局(FDA)2004年发布的"把基础发现带到可以到达病人手中的市场过程中存在的不断增长的危机"的报告内容及意义展现给读者,结合我国国情加以分析和评价。结果与结论安全性、医疗用途及产业化可行性是新医药产品开发的关键路径中的3个彼此相关的要素;运用现代化手段改进产品研发和评估过程,实现现代化监管,是解决问题的关键路径。希望该报告能够对我国的医药监管有所启示。

Objective The slowdown in new medical products reaching patients in recent years despite growing public and private investment in R＆D and tremendous progress in the basic biomedical sciences illustrates that better biomedical ideas alone are not enough. We must also ensure the successful movement of those ideas along the critical path of development, ultimately delivering reliable, safe, and effective treatments to patients at affordable prices. The purpose of this article is to arouse thinking from readers, so as to find reasons for this issue and way of settlement. Methods By way of introduction and commentary, the article unfolds the ideas and significance of FDA＇s report published in 2004 which is focused on the growing concern existed in the process of bringing basic scientific discovery into patient-reachable market, and makes analysis and remarks combining the situation in China. Results and Conclusions The report of FDA evaluates the reasons that have led to the crisis and provides a path of progress. The report mainly illustrates the efforts that FDA has made in improving the critical path, and discusses opportunities in future efforts. Finally, the teport calls on the industry and the academia to work together with FDA to find out key problems and constitutes methods of settlement. The final conclusion is. safety, medical use and industrialization are three interlinked factors in the critical path of new medical product development; the critical path to the settlement of the issue lies on the improvement of the process of product R＆D and evaluation with modern means and the realization of modern administration. It is the expectation of the article that the report can be somewhat an inspiration to the drug administration in China.