美国新药临床试验期间沟通交流机制简介与思考

Introduction and consideration of communication during the clinical trial of new drugs in the U.S.

本文简要介绍了美国新药临床试验期间的沟通交流制度,从FDA新药沟通交流的理念、时机和内容、方式与时限以及沟通交流的程序几个方面进行阐述。同时结合我国药品审评审批制度改革以来沟通交流制度建立和实施情况,对两国的沟通交流制度进行了对比和思考。

This paper briefly introduces the communication between the sponsors and FDA during the clinical trial of new drugs,including FDA’s philosophy regarding communication,as well as when and how to request a formal meeting.The establishment and implementation of communication system and thinking are compared between China and U.S.after the drug review and approval revolution.