共同审评审批制度下药用辅料质量监管的思考

Considerations of the regulation of pharmaceutical excipients' quality under China's joint review system

本文旨在研究我国共同审评审批制度对于药用辅料监管的相关规定,思考完善我国药用辅料的监管制度。以我国药用辅料的监管制度为研究对象,通过文献研究梳理我国药品共同审评审批制度改革中与药用辅料监管相关的措施,结合我国药用辅料行业现有的国情,归纳我国药品共同审评审批制度改革的主要变化及与美国DMF备案管理制度在药用辅料领域的异同点,并提出进一步的思考。我国药品共同审评审批制度有利于缩短药用辅料的审评时间、节约政府的监管资源、减轻企业的整体负担、提高药用辅料的质量;共同审评审批制度可以通过引入社会共治理念、理清各方主体责任,进一步提高我国药品的整体质量。

The objective of this article was to research the laws and regulations of pharmaceutical excipients under China’s joint review system and provide reference for perfecting China’s regulatory system of pharmaceutical excipients. Focusing on China’s regulatory system of pharmaceutical excipients,major measures and changes related to the regulation of pharmaceutical excipients in China’s reform of joint review,similarities and differences between China and US were reviewed by sorting out China’s laws and regulations. China’s reform of joint review system may help to shorten pharmaceutical excipients’ review time,save goverment’s regulatory resources,reduce burden of enterprises and improve the quality of pharmaceutical excipients. Joint review system may need the introduction of social co-governance concept to clarify the main responsibilities of all parties to further improve the overall drug quality in China.