3The importance ofpharmacovigilance: safety monitoring of medicinal products[M]. Geneva: World Health Organization, 2002.
4ICH.Clinical Safety Data Management:Periodic SafetyUpdate Reports for Marketed Drugs E2C(R1)(Nov.2005)[EB/OL].[2011-09-13].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/Step4/E2C_R1__Guideline.pdf.
5EMA.VOLUME9A of The Rules Governing Medicinal P r o d u c t s i n t h e E u r o p e a n U n i o n,G u i d e l i n e s o n Pharmacovigilance for Medicinal Products for Human Use(Sept.2008)[EB/OL].[2011-09-16].http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf.
6FDA.Guidance for Industry Addendum to E2C Clinical Safety Data Management:Periodic Safety Update Reports for Marketed Drugs(Feb.2004)[EB/OL].[2011-09-16].http://www.fda.gov/downloads/Drugs/GuidanceCompliance RegulatoryInformation/Guidances/UCM073105.pdf.