[Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments)]

Zhongguo Zhong Yao Za Zhi. 2013 Sep;38(18):2919-24.
[Article in Chinese]

Abstract

It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.

Publication types

  • English Abstract
  • Research Support, Non-U.S. Gov't

MeSH terms

  • China / epidemiology
  • Drug Monitoring / adverse effects
  • Drug Monitoring / standards
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Drug-Related Side Effects and Adverse Reactions / etiology
  • Drugs, Chinese Herbal / adverse effects
  • Drugs, Chinese Herbal / standards*
  • Hospital Information Systems
  • Humans
  • Product Surveillance, Postmarketing / methods
  • Product Surveillance, Postmarketing / standards*

Substances

  • Drugs, Chinese Herbal