关于加强我国疫苗临床试验监管的思考(下)

Considerations on strengthening the supervision of vaccine clinical trials in China(PartⅡ)

在新的疫苗临床试验发展形势下,监管部门应通过构建疫苗临床试验全方位立体监管模式来提高疫苗临床试验监管效能,其前提和基础是开展疫苗临床试验机构资格认定。本文提出了疫苗临床试验机构资格认定的实施方案建议,并探索了构建包括过程监管、事前监管和事后监管在内的疫苗临床试验全方位立体监管模式的实施方法。

In the new situation of the development of vaccine clinical trials,the regulatory authorities need to build the comprehensive three-dimensional vaccine clinical trial regulatory model,whose premise and basis is qualification for vaccine clinical trial institution,to improve the effectiveness of supervision.This paper presented the implementation proposals of qualification for vaccine clinical trial institution,and explored the implementation of the building the comprehensive three-dimensional vaccine clinical trial regulatory model,including the process supervision,previous supervision and postmortem supervision.