Discussion on adverse reactions monitoring modes of drug manufacturers under new measures for administration of adverse drug reaction report and monitoring.
- Author:
Yan-Yin YANG
1
;
Zhi DONG
;
Yong-Peng XIA
Author Information
- Publication Type:Journal Article
- MeSH: Adverse Drug Reaction Reporting Systems; Drug Industry; Drug-Related Side Effects and Adverse Reactions; diagnosis; Humans
- From: China Journal of Chinese Materia Medica 2012;37(21):3329-3333
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo discuss the modes for smooth progress of ADR monitoring under the new Measures for the Administration of Adverse Drug Reaction Report and Monitoring.
METHODWork modes for ADR monitoring in drug manufacturers were explored by explaining the new Measures and analyzing current state and constrains.
RESULT AND CONCLUSIONAs 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.
