参考文献（References）

［1］WHO Collaborating Centre for International Drug Monitoring.The importance of pharmacovigilance-safety monitoring of medicinal products.［2020-8-1］.http：//archives.who.int/tbs/safety/s4893e.pdf.

［2］FDA.CFR-Code of Federal Regulations Title 21.［2020-8-1］.http：//www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfcfr/cfrsearch.Cfm.

［3］SHIEL W C，STÖPPLE M C.Webster's New WorldTM Medical Dictionary.3rd ed.Indianapolis：Wiley Publishing Inc.，2008.

［4］EMA.ICH E2A Clinical Safety Data Management：Definitions and Standards for Expedited Reporting.Medford：GMP Publications Inc.，1994.