Discussion on adverse reactions monitoring modes of drug manufacturers under new measures for administration of adverse drug reaction report and monitoring
Yang, Y-Yin.; Dong, Z.; Xia, Y-Peng.
Zhongguo Zhong Yao Za Zhi 37(21): 3329-3333
2012
ISSN/ISBN: 1001-5302 PMID: 23397739 Document Number: 659448
To discuss the modes for smooth progress of ADR monitoring under the new Measures for the Administration of Adverse Drug Reaction Report and Monitoring. Work modes for ADR monitoring in drug manufacturers were explored by explaining the new Measures and analyzing current state and constrains. As there is a larger gap between the requirements of new Measures and current status, it is difficult for drug manufacturers to meet all the requirements in short-term. Therefore, drug manufacturers are suggested to gradually complete ADR monitoring under the mode of one platform and four expansions, and thereby finally meeting the requirements of new Measures and fulfilling their duties and missions.