OBJECTIVE: To provide references for perfecting the drug safety supervision mechanisms in China. METHODS: Based on the theory of “market failure”“contract failure” and “government failure”, representative drug safety supervision mechanisms were selected from USA for analysis and evaluation. RESULTS & CONCLUSIONS: USA has made some achievements in the implementation and application of drug safety supervision mechanisms. The representative drug safety supervision mechanisms included prescription drug applicant payment mechanism, drug safety information communication mechanism, punishment and incentive mechanism, public-private partnership mechanism, passive monitoring and active monitoring combination mechanism. These mechanisms relieved “government failure” of FDA, and solved the problems of “market failure” and “contract failure” to certain extent. In China, drug safety supervision mechanisms should be perfected from refining the legal guarantee, mobilizing external forces completely, absorbing and applying modern information technology, focusing on both prevention and disposal, paying attention to the coordination of different mechanism, striving for open procedure and transparent result.
关键词
药品安全监管机制美国研究启示
Keywords
Drug safetySupervision mechanismUSAStudyEnlightenment