摘要
目的 比较分析并针对性借鉴美国、欧盟、日本新药特殊审评模式经验。方法 通过梳理美国、欧盟和日本几种新药特殊审评模式,分析作用机制与实施绩效,进而总结模式特点,并根据我国新药注册审评改革情况提出针对性借鉴建议。结果 与美欧日相比,现阶段我国新药特殊审评正逐步注重临床疗效价值优势,但是模式设置上仍存在较大差距。结论 建议借鉴国外“多通道、全覆盖”的理念,在完善我国优先审评模式的基础上,逐步建立与完善多通道的新药特殊审评模式体系,从而全方位加快具有临床高价值药物的上市进程。
Abstract
OBJECTIVE To make a comparative analysis on the expedited approach for new drug review in the USA, the European Union, and Japan, and to provide references for China.METHODS Through analyzing the mechanism and implementation performance of each expedited approach, and summarizing its characteristics, this paper puts forward some suggestions according to the situation of the reform for new drug review in China. RESULTS Compared with the US, EU and Japan, our country is gradually laying emphasis on the value of clinical curative effect when to apply expedited approach, but there is still a large gap on system setting. CONCLUSION Hence this paper suggests to draw lessons from foreign "multi-channel, full coverage" concept, and gradually to establish a new multi-channel system of expedited review approach on the basis of perfecting our country′s priority review approach, thereby accelerating the process of new drugs which have high clinical value.
关键词
新药注册 /
特殊审评模式 /
国外比较
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Key words
new drug registration /
expedited review approach /
foreign comparision
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姚雪芳,丁锦希,李鹏辉,张晓明,陈烨.
国外新药特殊审评模式比较与借鉴[J]. 中国药学杂志, 2016, 51(19): 1714-1720 https://doi.org/10.11669/cpj.2016.19.019
YAO Xue-fang, DING Jin-xi, LI Peng-hui, ZHANG Xiao-ming, CHEN Ye.
Comparison and Reference of Foreign Expedited Approach for New Drug Review[J]. Chinese Pharmaceutical Journal, 2016, 51(19): 1714-1720 https://doi.org/10.11669/cpj.2016.19.019
中图分类号:
R951
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参考文献
TAO X M,DONG J P, HUANG L, et al. Relationship of ecosystems and resolution of new drug research and development. Chin Pharm J(中国药学杂志),2016,51 (7) :595-596.
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FDA. Guidance for Industry:Expedited Programs for Serious ConditionsDrugs and Biologics. 2015-12-30. http://www. fda. gov/downloads/drugs/guidancecompliance-regulatoryinformation/guidances/ucm358301. pdf
FDA. Fast Track Drug DevelopmentPrograms – Designation,Development, and ApplicationReview. 2015-12-30. http://www. fda. gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm073515. htm
FDA. Investigator-Initiated Investigational New Drug (IND) Applications . 2015-12-30. http://www. fda. gov/Drugs/DevelopmentApprovalProcess. htm
WALKER G,SHI Z X,CHEN J. Breakthrough therapy designation: a new expedited approval pathway in the US . Prog Pharm Sci(药学进展), 2013, 37(11):605-606.
EU Regulation: (EC) No 726/2004. 2015-12-30. http://ec. europa. eu/health/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en. pdf
Japan Pharmaceutical Manufacturers Association. Pharmaceutical Administration and Regulations in Japan. 2015-12-30. http://www. jpma. or. jp/english/parj/pdf/2015. pdf
Sonia Ribeiro. Experience with early access tools in centralised procedure. 2015-12-30. http://ec. europa. eu/health/files/committee/stamp/stamp_stamp_agenda_point_6_c_early_access_tools_in_cp_en. pdf
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脚注
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基金
国家社会科学基金资助项目《TRIPS协议框架下中国药品试验数据保护制度研究》(13BFX120);国家药品审评中心(CDE)委托课题《国外药品注册审评法规科学和评价策略研究》
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