我国实施湿热灭菌药品参数放行可行性研究

Feasibility Study of Implementing Parameter Release of Moist Heat Sterilized Drugs in China

本文从湿热灭菌药品国际实施参数放行的背景与现状、国内实施参数放行试点进展情况、我国实施参数放行的可行性评估以及下一步监管工作的建议4个方面进行论述,为湿热灭菌药品参数放行在我国的进一步实施提供科学依据。

This paper discusses the background and current situation of parametric release of moist heat sterilized drugs implemented worldwide,the domestic progress of implementation on parametric release,the feasibility assessment of this implementation in China,and the recommendations for future regulatory,which provides a scientific reference for accelerating the implementation on parametric release of moist heat sterilized drug in China.