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Drug Safety Evaluation in China.

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اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • المؤلفون: Li L;Li L; Yin J; Yin J
  • المصدر:
    Current allergy and asthma reports [Curr Allergy Asthma Rep] 2019 Jul 18; Vol. 19 (9), pp. 39. Date of Electronic Publication: 2019 Jul 18.
  • نوع النشر :
    Historical Article; Journal Article; Review
  • اللغة:
    English
  • معلومة اضافية
    • المصدر:
      Publisher: Current Science Inc Country of Publication: United States NLM ID: 101096440 Publication Model: Electronic Cited Medium: Internet ISSN: 1534-6315 (Electronic) Linking ISSN: 15297322 NLM ISO Abbreviation: Curr Allergy Asthma Rep Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: Philadelphia, PA : Current Science Inc., c2001-
    • الموضوع:
      Drug-Related Side Effects and Adverse Reactions*; Adverse Drug Reaction Reporting Systems/*standards ; Product Surveillance, Postmarketing/*methods; Adverse Drug Reaction Reporting Systems/history ; Adverse Drug Reaction Reporting Systems/legislation & jurisprudence ; China ; Government Regulation ; History, 20th Century ; History, 21st Century ; Humans ; Pharmacovigilance ; Product Surveillance, Postmarketing/standards
    • نبذة مختصرة :
      Purpose of Review: This review aimed to introduce the regulations management and current situations of drug safety evaluation in China.
      Recent Findings: The nationwide implementation of good laboratory practice and good clinical practice guarantees the quality of pre-marketing drug safety evaluation. In recent years, post-marketing drug safety monitoring is changing from passive mode to the combination of active and passive monitoring. A national adverse drug reaction monitoring sentinel alliance has been created to actively identify, report, and evaluate adverse reactions, with more than 1.4 million cases reported in 2017. But the quality of the reports is not optimal, with few reports from drug manufacturers, low rate of severe reports, and trend of lag reporting. Drug safety evaluation in China is transitioning from passive monitoring to a combination mode. Drug pharmacovigilance is a powerful tool for active monitoring, but participation by drug manufacturers would be essential to an effective drug safety evaluation system.
    • References:
      Zhongguo Zhong Yao Za Zhi. 2010 Nov;35(21):2882-8. (PMID: 21322952)
      J Ethnopharmacol. 2013 May 20;147(2):349-56. (PMID: 23541933)
      J Ethnopharmacol. 2015 Dec 24;176:321-6. (PMID: 26545459)
      Zhongguo Zhong Yao Za Zhi. 2015 Sep;40(18):3693-6. (PMID: 26983223)
      Sci Rep. 2016 Oct 04;6:34692. (PMID: 27698376)
    • Contributed Indexing:
      Keywords: Adverse drug reaction; China; Drug safety evaluation; Good clinical practice; Good laboratory practice; Traditional Chinese medicine
    • الموضوع:
      Date Created: 20190720 Date Completed: 20200427 Latest Revision: 20200427
    • الموضوع:
      20240628
    • الرقم المعرف:
      10.1007/s11882-019-0872-4
    • الرقم المعرف:
      31321555