介绍了美国进行新药临床试验和新药上市申请流程。中国药企向美国申请新药临床试验和新药上市申请时,应选择合适的临床适应症品种、提供充分的药学生产质量控制资料、准备严格规范的临床前安全性评价资料,并注意选择优质的申报代理。
[1] 国家食品药品监管总局.食药监总局关于解决药品注册申请积压实行优先审评审批的意见[EB/OL].[2016-02-26].http://www.sda.gov.cn/WS01/CL0844/145260.html.
[2] Food and Drug Administration, U.S.Department of Health and Human Services.21CFR part 312investigational new drugapplication[EB/OL].2015-04-01.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1.
[3] Food and Drug Administration, U.S.Department of Health and Human Services.Kefauver-Harris amendments revolutionized drug development [EB/OL].[2012-10-10].http://www.fda.gov/forconsumers/consumerupdates/ucm322856.htm.
[4] Jeanne Ireland.Food and Drug Administration Safety and Innovation Act (FDASIA) overview[EB/OL].2012-10-04.http://google2.fda.gov/search?q=Food+and+Drug+Administration+Safety+and+Innovation+Act+%28FDASIA%29+&client=FDAgov&site=FDAgov&lr&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd& getfields=*.
[5] Food and Drug Administration, U.S.Department of Health and Human Services.21CFR part 58 good laboratory practice for nonclinical laboratory studies[EB/OL].2015-04-01.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1.
[6] Food and Drug Administration, U.S.Department of Health and Human Services.21CFR part 50 protection of human subjects[EB/OL].2015-04-01.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1.
[7] Food and Drug Administration, U.S.Department of Health and Human Services.21CFR part 56 institutional review boards[EB/OL].2015-04-01.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=56&showFR=1.
[8] Food and Drug Administration, U.S.Department of Health and Human Services.21CFR part 314 applications for fda approval to market a new drug[EB/OL].2015-04-01.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314.
[9] Food and Drug Administration, U.S.Department of Health and Human Services.21CFR part 201 drug labeling[EB/OL].2015-04-01.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=201&showFR=1.
[10] Food and Drug Administration, U.S.Department of Health and Human Services.Fast track, breakthrough therapy, accelerated approval, priority review[EB/OL].[2015-09-14].http://www.fda.gov/forpatients/approvals/fast/default.htm.
[11] Food and Drug Administration, U.S.Department of Health and Human Services.21CFR part 316 orphan drugs[EB/OL].2015-04-01.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=316.
