1Lee, Ennis H, and Waller. Responding to Drug Safety Issues[J]. Pharmacoepidemiology and Drug Safety, 1999, 8:535-552.
2I Pledge Program:Committed to Pregnancy and isotretinoin Prevention [ EB/OL ]. 2009-05-06 [ 2009-09-20 ]. https://www. ipledgeprogram.com/Default.aspx.
3Public Law. Food and Drug Administration Amendments Act of 2007 [EB/OL].2009-05-06 [2009-09-20].http://frwebgate. access, gpo. gov/cgibin/getdoc, cgidbname=110_cong_public_ laws&docid=f:pub1085.110.pdf.
4VOLUME 9A of The Rules Governing Medicinal Products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human Use[EB/OL]. 2008-09[2009-09-20]. http://ec. europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/ pdf/vol9a.
5European Medicines Agency, Post-authorisation Evaluation of Medicines for Human Use [EB/OL]. 2009-05-0612009-09-20]. http://www.emea.europa.eu/pdfs/human/euleg/19263206en.pdf.
6Guidance for industry:E2E Pharmacovigilance Planning[EB/OL]. 2005-04[2009-09-20]. http://www.fda.gov/CbER/gdlns/ichpvp. htm.
7Eichler H G, Abadie E, Raine J M. Safe Drugs and the cost of good intentions[J].N Engl J Med, 2009,360:1378-1380.
8Fetterman, Jeffrey E, Pines.Pharmaceutical Risk Management: Practical Applications[J]. Washington DC:Food and Drug Law Institute, 2008.
9[1]Inman WH.Postmarketing surveillance of adverse drug reactions in general practice.II:Prescription-event monitoring at the University of Southampton[J].Br Med J (Clin Res Ed),1981,282(6271):1216-1217.
10[2]Inman WH.Prescription-event monitoring and yellow cards[J].Lancet,1984,1(8389):1301.