1EMEA.Clinical Safety Data Management:Periodic Safety Update Reports for Marketed Drugs E2C(R1)[EB/OL].[2010-01-03]http: //www.emea.europa.eu/pd fs/human/ich/028895en.pdf.
2FDA.E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting[EB/OL].[2010-01-03]http:// www.fda.gov/Regulatorylnformation/Guidances/ucm129457.htm.
3FDA.Guidance for Industry Addendum to E2C Clinical Safety Data Management:Periodic Safety Update Reports for Marketed Drugs [EB/OL]. [2010-01-03]http://www.fda.gov/downloads/Regulatory- Information/Guidances/UCM129455.pdf.
