About: Drug Safety Surveillance in China and Other Countries: A Review and Comparison

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An Entity of Type : schema:ScholarlyArticle, within Data Space : wasabi.inria.fr associated with source document(s)

Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Drug Safety Surveillance in China and Other Countries: A Review and Comparison
Creator	Du, Wenmin Jing, Yonghua Li, Xing Guo, Jeff Kelton, Christina
Source	Elsevier; Medline; PMC
abstract	Abstract Objectives Drug safety and postmarketing surveillance have become important public health issues in China. This study reviews the relatively new drug safety surveillance system in China and compares it with the systems in the United States and Europe. Methods An extensive literature review was conducted in the following four areas: 1) the organizational structure of the State Food and Drug Administration (SFDA) in China; 2) the development of an adverse drug reaction (ADR) monitoring system in China; 3) regulatory issues related to drug safety in China; and 4) similarities and differences between drug safety surveillance in China and surveillance in the United States and Europe. Results The SFDA oversees an extensive network of drug safety “watchdogs,” including the China National Center for ADR Monitoring and 32 regional centers throughout China. China's system has faced a number of recent challenges. It has had to respond quickly to the withdrawal of various high-profile drugs like Vioxx (rofecoxib) and Baycol (cerivastatin) from other markets. Together with China's Ministry of Health, the SFDA has faced several unique drug safety events. Three of those events, involving the injectable form of the heartleaf houttuyinia herb (Yu Xing Cao), Armillarisni A injections, and clindamycin glucose infusions (Xinfu), are discussed. The rapid development of drug safety surveillance in China is manifested in extensive organizational structure, development of large databases, and laws and regulations supporting drug safety. The two major laws are the China Drug Administration Law issued in February 2001 and the Regulation for the Administration of ADR Reporting and Monitoring issued in March 2004. The study also discusses and compares recent developments in drug safety surveillance in the United States and the European Union. These developments will most likely have implications for the Chinese system in the near future. Conclusions While postmarketing surveillance guidelines are not yet available in China, we fully expect their eventual issuance after adaptation to the particular culture and clinical practices in China.
has issue date	2008-04-30(xsd:dateTime)
bibo:doi	10.1111/j.1524-4733.2008.00377.x
bibo:pmid	18387057
has license	els-covid
sha1sum (hex)	164b052f51fac87145a66b4182f9a451442b9c7c
schema:url	https://doi.org/10.1111/j.1524-4733.2008.00377.x
resource representing a document's title	Drug Safety Surveillance in China and Other Countries: A Review and Comparison
has PubMed Central identifier	PMC7129404
has PubMed identifier	18387057
schema:publication	Value in Health
resource representing a document's body	covid:164b052f51fac87145a66b4182f9a451442b9c7c#body_text
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