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Volumn 11, Issue SUPPL. 1, 2008, Pages

Drug safety surveillance in China and other countries: A review and comparison

Author keywords

Adverse drug reaction; China; Drug safety; Surveillance

Indexed keywords

ARMILLARISNI A; CERIVASTATIN; CISAPRIDE; CLINDAMYCIN; CLINDAMYCIN PHOSPHATE GLUCOSE; DIETHYLENE GLYCOL; HEARTLEAF HOUTTUYINIA EXTRACT; HERBACEOUS AGENT; ROFECOXIB; TERFENADINE; TROGLITAZONE; UNCLASSIFIED DRUG; XINFU; YU XING CAO;

EID: 41749111808     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1111/j.1524-4733.2008.00377.x     Document Type: Conference Paper
Times cited : (20)

References (30)
  • 1
    • 0035291754 scopus 로고    scopus 로고
    • Drug-related morbidity and mortality: Updating the cost-of-illness model
    • Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: updating the cost-of-illness model. J Am Pharm Assoc 2001 41 : 192 9.
    • (2001) J Am Pharm Assoc , vol.41 , pp. 192-199
    • Ernst, F.R.1    Grizzle, A.J.2
  • 2
    • 0032522873 scopus 로고    scopus 로고
    • Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies
    • Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998 279 : 1200 5.
    • (1998) JAMA , vol.279 , pp. 1200-1205
    • Lazarou, J.1    Pomeranz, B.H.2    Corey, P.N.3
  • 3
    • 13444263619 scopus 로고    scopus 로고
    • Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: Nested case-control study
    • Graham DJ, Campen D, Hui R, et al. Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005 365 : 475 81.
    • (2005) Lancet , vol.365 , pp. 475-481
    • Graham, D.J.1    Campen, D.2    Hui, R.3
  • 4
    • 41749119336 scopus 로고    scopus 로고
    • Center for Drug Re-evaluation. State food and drug administration of China. ADR reporting and monitoring in China. Available from: [Accessed October 31, 2006].
    • Center for Drug Re-evaluation. State food and drug administration of China. ADR reporting and monitoring in China. Available from: http://www.who-umc.org [Accessed October 31, 2006].
  • 5
    • 33745712604 scopus 로고    scopus 로고
    • An overview of adverse drug reaction monitoring in China
    • Zhou Y, Miller V, Hogan M, Callahan L. An overview of adverse drug reaction monitoring in China. Int J Pharm Med 2006 20 : 79 85.
    • (2006) Int J Pharm Med , vol.20 , pp. 79-85
    • Zhou, Y.1    Miller, V.2    Hogan, M.3    Callahan, L.4
  • 6
    • 41749100073 scopus 로고    scopus 로고
    • Center for Drug Re-evaluation. SFDA. Available from: [Accessed October 31, 2006].
    • Center for Drug Re-evaluation. SFDA. Available from: http://www.cdr.gov. cn/index.jsp [Accessed October 31, 2006].
  • 8
    • 41749116322 scopus 로고
    • Clinical Safety Data Management. London: European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit, Available from: [Accessed October 31, 2006].
    • Clinical Safety Data Management. Definitions and Standards for Expedited Reporting. London : European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit, 1995. Available from: http://www.emea.eu.int/ pdfs/human/ich [Accessed October 31, 2006].
    • (1995) Definitions and Standards for Expedited Reporting.
  • 9
    • 41749121646 scopus 로고    scopus 로고
    • Chinese Medical Institute & Register. Code of Conduct and Good Practice. Available from: [Accessed April 12, 2007].
    • Chinese Medical Institute & Register. Code of Conduct and Good Practice. Available from: http://www.cmir.org.uk [Accessed April 12, 2007].
  • 10
    • 41749110630 scopus 로고    scopus 로고
    • State Food and Drug Administration of China (SFDA). Drug administration law of the People's Republic of China. Available from: [Accessed October 31, 2006].
    • State Food and Drug Administration of China (SFDA). Drug administration law of the People's Republic of China. Available from: http://www.sfda.gov.cn/ cmsweb/webportal [Accessed October 31, 2006].
  • 11
    • 41749124932 scopus 로고    scopus 로고
    • China Ministry of Health & SFDA. Regulation for the administration of adverse drug reaction report and monitoring. Available from: [Accessed October 31, 2006].
    • China Ministry of Health & SFDA. Regulation for the administration of adverse drug reaction report and monitoring. Available from: http://www.cdr.gov.cn/doc/content [Accessed October 31, 2006].
  • 12
    • 41749091971 scopus 로고    scopus 로고
    • State Food and Drug Administration of China. Laws and regulations. Available from: [Accessed October 31, 2006].
    • State Food and Drug Administration of China. Laws and regulations. Available from: http://www.sfda.gov.cn/cmsweb/webportal [Accessed October 31, 2006].
  • 13
    • 85048354693 scopus 로고    scopus 로고
    • Needs for post-marketing evaluations in China
    • Cheng RL. Needs for post-marketing evaluations in China. Chin J Pharmacovigilance 2005 2 : 220 5.
    • (2005) Chin J Pharmacovigilance , vol.2 , pp. 220-225
    • Cheng, R.L.1
  • 14
    • 41749090844 scopus 로고    scopus 로고
    • The network of ADRs monitoring in China. Available from: [Accessed October 31, 2006].
    • The network of ADRs monitoring in China. Available from: http://www.adr.gov.cn [Accessed October 31, 2006].
  • 15
    • 41749102110 scopus 로고    scopus 로고
    • On the event of 'Exigent Withdrawal of Houttuynia Cordata Injection'
    • Met Q, Zeng C. On the event of 'Exigent Withdrawal of Houttuynia Cordata Injection'. China Pharm 2006 17 : 1124 6.
    • (2006) China Pharm , vol.17 , pp. 1124-1126
    • Met, Q.1    Zeng, C.2
  • 16
    • 41749087285 scopus 로고    scopus 로고
    • Center of Drug Reevaluation, SFDA. Questions and answers about the temporally withdrawal of houttuynia herb injections from the market. Available from: [Accessed October 31, 2006].
    • Center of Drug Reevaluation, SFDA. Questions and answers about the temporally withdrawal of houttuynia herb injections from the market. Available from: http://www.cdr.gov.cn/docbase/infodata [Accessed October 31, 2006].
  • 17
    • 41749104393 scopus 로고    scopus 로고
    • The analysis of ADRs related to houttuynia herb injections
    • Wang Y, Tang Z. The analysis of ADRs related to houttuynia herb injections. Chin J New Drugs 2006 15 : 739 41.
    • (2006) Chin J New Drugs , vol.15 , pp. 739-741
    • Wang, Y.1    Tang, Z.2
  • 18
    • 41749119100 scopus 로고    scopus 로고
    • Center of Drug Reevaluation, SFDA. Warning about the ADRs related to houttuynia herb injections. Available from: [Accessed October 31, 2006].
    • Center of Drug Reevaluation, SFDA. Warning about the ADRs related to houttuynia herb injections. Available from: http://www.cdr.gov.cn/doc/ [Accessed October 31, 2006].
  • 19
    • 41749099844 scopus 로고    scopus 로고
    • Center of Drug Reevaluation, SFDA. The new developments and progressions of ADR monitoring and regulations in China. Available from: [Accessed October 31, 2006].
    • Center of Drug Reevaluation, SFDA. The new developments and progressions of ADR monitoring and regulations in China. Available from: http://www.cdr.gov. cn/ [Accessed October 31, 2006].
  • 20
    • 41749086137 scopus 로고    scopus 로고
    • State Food and Drug Administration of China. The notice about the temporally withdrawal of houttuynia herb injections from the market. Available from: [Accessed October 31, 2006].
    • State Food and Drug Administration of China. The notice about the temporally withdrawal of houttuynia herb injections from the market. Available from: http://www.sfda.gov.cn/eng/ [Accessed October 31, 2006].
  • 21
    • 41749085906 scopus 로고    scopus 로고
    • State Food and Drug Administration of China. The notice about the regulations of the seven houttuynia herb injections. Available from: [Accessed October 31, 2006].
    • State Food and Drug Administration of China. The notice about the regulations of the seven houttuynia herb injections. Available from: http://www.sfda.gov.cn/eng/ [Accessed October 31, 2006].
  • 22
    • 41749120032 scopus 로고    scopus 로고
    • State Food and Drug Administration of China. The National report about Xinfu ADRs by August 13, 2006. Available from: [Accessed September 22, 2006].
    • State Food and Drug Administration of China. The National report about Xinfu ADRs by August 13, 2006. Available from: Http://News.Sohu.Com/S2006/Xinfu/ [Accessed September 22, 2006].
  • 23
    • 41749116323 scopus 로고    scopus 로고
    • China Daily. Drug that has sickened dozens banned. Available from: [Accessed September 22, 2006].
    • China Daily. Drug that has sickened dozens banned. 2006-08-04. Available from: http://www.chinadaily.com.cn/china/2006-08/04 [Accessed September 22, 2006].
    • (2006)
  • 24
    • 41749083883 scopus 로고    scopus 로고
    • State Food and Drug Administration of China. The investigation results of clindamycin phosphate glucose injection produced by the Anhui Huayuan Pharmacy Co. Available from: [Accessed October 31, 2006].
    • State Food and Drug Administration of China. The investigation results of clindamycin phosphate glucose injection produced by the Anhui Huayuan Pharmacy Co. Available from: http://www.sfda.gov.cn/cmsweb/webportal [Accessed October 31, 2006].
  • 25
    • 41749088190 scopus 로고    scopus 로고
    • China government cited in medicine probe. Wall Street Journal. Available from: [Accessed April 8, 2007].
    • Zamiska N, Hanting T. China government cited in medicine probe. Wall Street Journal. 2007-02-09. Available from: http://online.wsj.com [Accessed April 8, 2007].
    • (2007)
    • Zamiska, N.1    Hanting, T.2
  • 26
    • 41749085907 scopus 로고    scopus 로고
    • United States FDA. FDA issues final risk minimization guidance. Available from: [Accessed October 31, 2006].
    • United States FDA. FDA issues final risk minimization guidance. Available from: http://www.fda.gov/bbs/topics/news/2005 [Accessed October 31, 2006].
  • 27
    • 41749104798 scopus 로고    scopus 로고
    • FDA. Premarketing risk assessment guidance. Available from: [Accessed October 31, 2006].
    • FDA. Premarketing risk assessment guidance. Available from: http://www.fda.gov/cder/guidance [Accessed October 31, 2006].
  • 28
    • 41749099405 scopus 로고    scopus 로고
    • FDA. Development and use of risk minimization action plans. Available from: [Accessed October 31, 2006].
    • FDA. Development and use of risk minimization action plans. Available from: http://www.fda.gov/cder/guidance [Accessed October 31, 2006].
  • 29
    • 41749111515 scopus 로고    scopus 로고
    • FDA. Good pharmacovigilance practices and pharmacoepidemiologic assessment. Available from: [Accessed October 31, 2006].
    • FDA. Good pharmacovigilance practices and pharmacoepidemiologic assessment. Available from: http://www.fda.gov/cder/guidance [Accessed October 31, 2006].
  • 30
    • 41749111072 scopus 로고    scopus 로고
    • European Medicine Agency (EMeA). Guideline on risk management systems for medicinal products for human use. Available from: [Accessed October 31, 2006].
    • European Medicine Agency (EMeA). Guideline on risk management systems for medicinal products for human use. Available from: http://www.emea.eu.int/pdfs/ human [Accessed October 31, 2006].


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.