欧美政府和企业应对抗生素耐药战略决策和行动计划概述
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摘要
抗生素耐药已成为威胁人类健康的全球性问题。作为抗生素行业的领导者,欧美政府部门和制药公司已积极行动起来,讨论并发布了一系列应对抗生素耐药的改革意见和方案。本文对其近期出台的相关指南和指导性文件进行简要解读,为我国抗生素研发行业改革提供参考。
Antibiotic resistance has become a global threat to human health. As the leaders of the antibiotic industry, the European and US government and the pharmaceutical industry alliances have taken positive actions and issued a series of reforms and action plans to combat the antibiotics resistance. This paper gives a brief interpretation of these recently published documents and provides valuable suggestions for domestic antibiotic industry reform.
Antibiotic resistance has become a global threat to human health. As the leaders of the antibiotic industry, the European and US government and the pharmaceutical industry alliances have taken positive actions and issued a series of reforms and action plans to combat the antibiotics resistance. This paper gives a brief interpretation of these recently published documents and provides valuable suggestions for domestic antibiotic industry reform.
引文
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[2]Spellberg B,Bartlett JG,Gilbert DN,et al.The Future of Antibiotics and Resistance[J].New Engl J Med,2013,368(4):299-302.
[3]FDA.Guidance for Industry(draft guidance)Qualified infectious disease product designation questions and answers.[EB/OL].2018-01-29.https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm594213.pdf.
[4]IMI.Revitalizing the antibiotic pipeline-Stimulating innovation while driving sustainable use and global access[EB/OL].2018-01-24.http://www.carb-x.org/files/DRIVE-AB_Final_Report-Jan2018.pdf.
[5]SUSTAINABILITY.Tracking progress to address AMR-AMR Industry Alliance Annual Report 2018[EB/OL].2018-01-18.https://www.amrindustryalliance.org/.
[6]FDA.Guidance for industry Expedited programs for serious conditions-drugs and biologics.[EB/OL].2017-09-22.https://www.fda.gov/ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/ucm358301.pdf.
[7]Holmes A,Moore LS,Sundsfjord A,et al.Understanding the mechanisms and drivers of antimicrobial resistance.[J].The Lancet,2016,387(10014):176-187.
[8]Silver LL.The antibiotic future.Topics in Medicinal Chemistry[M].Springer Berlin Heidelberg,2017:1-37.
[9]Harbarth S,Theuretzbacher U,Hackett J,et al.Antibiotic research and development:business as usual?[J].JAntimicrob Chemoth,2015,70(6):1604-1607.
[10]Teillant A,Gandra S,Barter D,et al.Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA:a literature review and modelling study[J].Lancet Infect Dis,2015,15(12):1429-1437.
[11]Smith R,Coast J.Antimicrobial resistance:the true cost[J].BMJ(Clinical research ed),2013,346(7899):20-22.
[12]Liu L,Oza S,Hogan D,et al.Global,regional,and national causes of child mortality in 2000-13,with projections to inform post-2015 priorities:an updated systematic analysis.[J].The Lancet,2015;385(9966):430-440.
[13]Spellberg B,Sharma P,Rex JH.The critical impact of time discounting on economic incentives to overcome the antibiotic market failure[J].Nat Rev Drug Discov,2012,11(2):168-171.
[14]OECD,WHO,FAO,OIE.Tackling Antimicrobial Resistance,Ensuring Sustainable R&D[EB/OL].2017-06-29.http://www.oecd.org/els/health-systems/G20-AMR-Final-Paper-2017.pdf.
[15]BusinessWire.The Medicines Company Announces Definitive Agreement to Sell its Infectious Disease Business Unit to Melinta Therapeutics[EB/OL].2017-11-2 9 We b.h t t p s://w w w.b u s i n e s s w i r e.c o m/n e w s/home/20171129005573/en/.
[16]IFPMA.Industry Roadmap for Progress on Combating Antimicrobial Resistance[EB/OL].2016-09.https://www.ifpma.org/wp-content/uploads/2016/09/Roadmap-forProgress-on-AMR-FINAL.pdf.
[17]FDA.Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases guidance for industry[EB/OL].2017-08-01.https://www.fda.gov/downloads/Drugs/Guidance C o m p l i a n c e R e g u l a t o r y I n f o r m a t i o n/G u i d a n c e s/UCM359184.pdf
[18]萧惠来.FDA“未满足治疗严重细菌性疾病医疗需要患者的抗菌治疗指导原则”介绍[J].药物评价研究,2018,41(1):41-47.
[2]Spellberg B,Bartlett JG,Gilbert DN,et al.The Future of Antibiotics and Resistance[J].New Engl J Med,2013,368(4):299-302.
[3]FDA.Guidance for Industry(draft guidance)Qualified infectious disease product designation questions and answers.[EB/OL].2018-01-29.https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm594213.pdf.
[4]IMI.Revitalizing the antibiotic pipeline-Stimulating innovation while driving sustainable use and global access[EB/OL].2018-01-24.http://www.carb-x.org/files/DRIVE-AB_Final_Report-Jan2018.pdf.
[5]SUSTAINABILITY.Tracking progress to address AMR-AMR Industry Alliance Annual Report 2018[EB/OL].2018-01-18.https://www.amrindustryalliance.org/.
[6]FDA.Guidance for industry Expedited programs for serious conditions-drugs and biologics.[EB/OL].2017-09-22.https://www.fda.gov/ucm/groups/fdagov-public/@fdagovdrugs-gen/documents/document/ucm358301.pdf.
[7]Holmes A,Moore LS,Sundsfjord A,et al.Understanding the mechanisms and drivers of antimicrobial resistance.[J].The Lancet,2016,387(10014):176-187.
[8]Silver LL.The antibiotic future.Topics in Medicinal Chemistry[M].Springer Berlin Heidelberg,2017:1-37.
[9]Harbarth S,Theuretzbacher U,Hackett J,et al.Antibiotic research and development:business as usual?[J].JAntimicrob Chemoth,2015,70(6):1604-1607.
[10]Teillant A,Gandra S,Barter D,et al.Potential burden of antibiotic resistance on surgery and cancer chemotherapy antibiotic prophylaxis in the USA:a literature review and modelling study[J].Lancet Infect Dis,2015,15(12):1429-1437.
[11]Smith R,Coast J.Antimicrobial resistance:the true cost[J].BMJ(Clinical research ed),2013,346(7899):20-22.
[12]Liu L,Oza S,Hogan D,et al.Global,regional,and national causes of child mortality in 2000-13,with projections to inform post-2015 priorities:an updated systematic analysis.[J].The Lancet,2015;385(9966):430-440.
[13]Spellberg B,Sharma P,Rex JH.The critical impact of time discounting on economic incentives to overcome the antibiotic market failure[J].Nat Rev Drug Discov,2012,11(2):168-171.
[14]OECD,WHO,FAO,OIE.Tackling Antimicrobial Resistance,Ensuring Sustainable R&D[EB/OL].2017-06-29.http://www.oecd.org/els/health-systems/G20-AMR-Final-Paper-2017.pdf.
[15]BusinessWire.The Medicines Company Announces Definitive Agreement to Sell its Infectious Disease Business Unit to Melinta Therapeutics[EB/OL].2017-11-2 9 We b.h t t p s://w w w.b u s i n e s s w i r e.c o m/n e w s/home/20171129005573/en/.
[16]IFPMA.Industry Roadmap for Progress on Combating Antimicrobial Resistance[EB/OL].2016-09.https://www.ifpma.org/wp-content/uploads/2016/09/Roadmap-forProgress-on-AMR-FINAL.pdf.
[17]FDA.Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases guidance for industry[EB/OL].2017-08-01.https://www.fda.gov/downloads/Drugs/Guidance C o m p l i a n c e R e g u l a t o r y I n f o r m a t i o n/G u i d a n c e s/UCM359184.pdf
[18]萧惠来.FDA“未满足治疗严重细菌性疾病医疗需要患者的抗菌治疗指导原则”介绍[J].药物评价研究,2018,41(1):41-47.