浅析国内外药品临床试验期间药学变更的监管及技术评价考虑
摘要
<正>药品的临床试验(clinical trial,CT)是为确证药物在人体(患者或健康人群)中安全有效性而开展的系统性研究~([1]),其时间跨度通常为3～8年,见图1。临床试验研究是一个对药品不断加深理解和成药性确定的过程,因此,申请人(sponsor)通常会根据临床验证的人体结果逐步进行药学开发的调整,如改进
引文
[1]XIE J Q.Discussion on the quality control and assurance systems of drug clinical trials[J].China Pharmacist,2015,18(7):1191-1194.(in Chinese)谢洁琼.药物临床试验质量控制与质量保证体系探讨[J].中国药师,2015,18(7):1191-1194.
[2]田少雷,刘晓梅.药品临床试验申办者的职责[J].中国医药导刊,2000,2(6):52-52,44.
[3]刘浩,李素梅.生命周期理论在药品生产和质量管理中的应用[J].黑龙江医药,2017,30(5):982-986.
[4]向雪.FDA生物制品的申报许可流程及要求[J].中国医药技术经济与管理,2012,6(5):86-91.
[5]European parliament,Council of the European Union.Rrgulation(EU)536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use,and repealing Directive 2001/20/EC[J].Official J EU,2014,L158:1-76.
[6]CDER,CBER.Content and format of Investigational New Drug Applications(INDs)for phase 1 studies of drugs,including well-characterized,therapeutic,biotechnology-derived products[OL].(1995-11-xx)[2018-08-12].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071597.pdf.1995.
[7]YU H,MA Y N.Introduction of the quality documentation requirements on investigational new drug applications for phase 1studies of drugs in FDA and EMA[J].Chin J Clin Pharmcol,2011,6(6):476-480.(in Chinese)于红,马玉楠.FDA与EMA关于化学药申请Ⅰ期临床试验相关药学质量文件要求简介[J].中国临床药理学杂志,2011,6(6):476-480.
[8]FDA.Guidance for Industry:INDs for phase 2 and phase 3 studies[OL].(2003-05-xx)[2018-08-12].https://www.gmpcompliance.org/guidelines/gmp-guideline/fda-guidance-for-industryinds-for-phase-2-and-phase-3-studies-chemistry-manufacturingand-controls-information.
[9]CFR-Code of Federal Regulations Title 21.312.31-Information amendments[OL].(2018-04-01)[2018-08-12].https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.31
[10]CDER.Good review practice:good review management principles and practices for effective IND development and review[OL].(2013-04-29)[2018-08-12].https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM349907.pdf.
[11]CFR-Code of Federal Regulations Title 21.312.33-Annual reports.[OL].(2018-04-01)[2018-08-12].https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.33
[12]WEI F F,SUN Y X,LENG J N,et al.Interpretation and reflection on the Reg.(EU)No 536/2014 of the European[J].Chin J N Drugs,2017,(16):1865-1872.(in Chinese)魏芬芳,孙宇昕,冷金诺,等.对欧盟临床试验法规Reg.(EU)No 536/2014的解读与思考[J].中国新药杂志,2017,26(16):1865-1872.
[13]IMPD.Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials[OL].(2006-03-xx)[2018-08-12].http://www.imp-dossier.eu/imdp_guidance/.
[14]European Commission(EC).Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities,notification of substantial amendments and the declaration of the end of the trial[OL].https://ec.europa.eu/health//sites/health/files/files/clinicaltrials/docs/pc_rev3_2009-11/collins_rory_en.pdf.
[15]EMA.Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials[OL].(2010-02-18)[2018-08-12].https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2012-05_quality_for_biological.pdf.
[16]FDA.Guidance for Industry:IND meetings for human drugs and biologics[OL].(2001-05-xx)[2018-08-12].http://www.thefederalregister.com/2001/05/25/01-13249.html.
[17]国家药品审评中心(CDE).关于新法规品种临床期间修改处方工艺的几点建议[R/OL].(2009-08-13)[2018-08-12].http://www.cde.org.cn/dzkw.do?method=largePage&id=311349
[18]房军.创新诚信提升从制药大国向制药强国迈进--"十三五"国家药品安全规划解读[J].中国食品药品监管,2017,15(10):31-33.
[2]田少雷,刘晓梅.药品临床试验申办者的职责[J].中国医药导刊,2000,2(6):52-52,44.
[3]刘浩,李素梅.生命周期理论在药品生产和质量管理中的应用[J].黑龙江医药,2017,30(5):982-986.
[4]向雪.FDA生物制品的申报许可流程及要求[J].中国医药技术经济与管理,2012,6(5):86-91.
[5]European parliament,Council of the European Union.Rrgulation(EU)536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use,and repealing Directive 2001/20/EC[J].Official J EU,2014,L158:1-76.
[6]CDER,CBER.Content and format of Investigational New Drug Applications(INDs)for phase 1 studies of drugs,including well-characterized,therapeutic,biotechnology-derived products[OL].(1995-11-xx)[2018-08-12].https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071597.pdf.1995.
[7]YU H,MA Y N.Introduction of the quality documentation requirements on investigational new drug applications for phase 1studies of drugs in FDA and EMA[J].Chin J Clin Pharmcol,2011,6(6):476-480.(in Chinese)于红,马玉楠.FDA与EMA关于化学药申请Ⅰ期临床试验相关药学质量文件要求简介[J].中国临床药理学杂志,2011,6(6):476-480.
[8]FDA.Guidance for Industry:INDs for phase 2 and phase 3 studies[OL].(2003-05-xx)[2018-08-12].https://www.gmpcompliance.org/guidelines/gmp-guideline/fda-guidance-for-industryinds-for-phase-2-and-phase-3-studies-chemistry-manufacturingand-controls-information.
[9]CFR-Code of Federal Regulations Title 21.312.31-Information amendments[OL].(2018-04-01)[2018-08-12].https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.31
[10]CDER.Good review practice:good review management principles and practices for effective IND development and review[OL].(2013-04-29)[2018-08-12].https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/UCM349907.pdf.
[11]CFR-Code of Federal Regulations Title 21.312.33-Annual reports.[OL].(2018-04-01)[2018-08-12].https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.33
[12]WEI F F,SUN Y X,LENG J N,et al.Interpretation and reflection on the Reg.(EU)No 536/2014 of the European[J].Chin J N Drugs,2017,(16):1865-1872.(in Chinese)魏芬芳,孙宇昕,冷金诺,等.对欧盟临床试验法规Reg.(EU)No 536/2014的解读与思考[J].中国新药杂志,2017,26(16):1865-1872.
[13]IMPD.Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials[OL].(2006-03-xx)[2018-08-12].http://www.imp-dossier.eu/imdp_guidance/.
[14]European Commission(EC).Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities,notification of substantial amendments and the declaration of the end of the trial[OL].https://ec.europa.eu/health//sites/health/files/files/clinicaltrials/docs/pc_rev3_2009-11/collins_rory_en.pdf.
[15]EMA.Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials[OL].(2010-02-18)[2018-08-12].https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/2012-05_quality_for_biological.pdf.
[16]FDA.Guidance for Industry:IND meetings for human drugs and biologics[OL].(2001-05-xx)[2018-08-12].http://www.thefederalregister.com/2001/05/25/01-13249.html.
[17]国家药品审评中心(CDE).关于新法规品种临床期间修改处方工艺的几点建议[R/OL].(2009-08-13)[2018-08-12].http://www.cde.org.cn/dzkw.do?method=largePage&id=311349
[18]房军.创新诚信提升从制药大国向制药强国迈进--"十三五"国家药品安全规划解读[J].中国食品药品监管,2017,15(10):31-33.