Research and Enlightenment on the Drug Safety Supervision Mechanisms in USA
10.6039/j.issn.1001-0408.2017.04.02
- VernacularTitle:美国药品安全监管机制研究及启示
- Author:
Li YANG
;
Lijuan TIAN
;
Gang LUO
- Keywords:
Drug safety;
Supervision mechanism;
USA;
Study;
Enlightenment
- From:
China Pharmacy
2017;28(4):437-441
- CountryChina
- Language:Chinese
-
Abstract:
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 mecha-nisms 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 in-centive 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 cer-tain extent. In China,drug safety supervision mechanisms should be perfected from refining the legal guarantee,mobilizing exter-nal forces completely,absorbing and applying modern information technology,focusing on both prevention and disposal,paying at-tention to the coordination of different mechanism,striving for open procedure and transparent result.
