Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance / 中国中药杂志
China Journal of Chinese Materia Medica
;
(24): 2943-2948, 2013.
Article
in Chinese
| WPRIM
| ID: wpr-238577
ABSTRACT
Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Product Surveillance, Postmarketing
/
Reference Standards
/
Drugs, Chinese Herbal
/
China
/
Adverse Drug Reaction Reporting Systems
/
Guidelines as Topic
/
Drug Therapy
/
Methods
Type of study:
Practice guideline
/
Screening study
Limits:
Humans
Country/Region as subject:
Asia
Language:
Chinese
Journal:
China Journal of Chinese Materia Medica
Year:
2013
Type:
Article
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