行政法学研究
行政法學研究
행정법학연구
ADMINISTRATIVE LAW REVIEW
2014年
3期
3-12
,共10页
药品审评%行政法%行政程序%全球行政法%治理网络
藥品審評%行政法%行政程序%全毬行政法%治理網絡
약품심평%행정법%행정정서%전구행정법%치리망락
Drug Review%Administrative Law%Administrative Procedure%Global Administrative Law%Governance Network
药品审评作为行政许可的表现形式，是一种重要的事先规制手段。通过建构行政治理网络，厘清政府部门与技术审评机构的关系，强化国家食品药品监督管理总局药品审评中心的能力建设，合理配置中央和地方权力，完善专家咨询制度，可以改进药品审评能力。通过制定药品审评程序规范，建构优先审评程序，完善沟通交流机制，恪守药品审评时限，可以简化和优化行政程序。未来应注意药品审评技术指导原则国际化与本土化的结合，制定适合中国实际需要的药品技术审评指导原则。《化学药品CTD 格式申报资料撰写要求》的颁布，凸显了全球行政法及药品审评国际化的趋势。
藥品審評作為行政許可的錶現形式，是一種重要的事先規製手段。通過建構行政治理網絡，釐清政府部門與技術審評機構的關繫，彊化國傢食品藥品鑑督管理總跼藥品審評中心的能力建設，閤理配置中央和地方權力，完善專傢咨詢製度，可以改進藥品審評能力。通過製定藥品審評程序規範，建構優先審評程序，完善溝通交流機製，恪守藥品審評時限，可以簡化和優化行政程序。未來應註意藥品審評技術指導原則國際化與本土化的結閤，製定適閤中國實際需要的藥品技術審評指導原則。《化學藥品CTD 格式申報資料撰寫要求》的頒佈，凸顯瞭全毬行政法及藥品審評國際化的趨勢。
약품심평작위행정허가적표현형식，시일충중요적사선규제수단。통과건구행정치리망락，전청정부부문여기술심평궤구적관계，강화국가식품약품감독관리총국약품심평중심적능력건설，합리배치중앙화지방권력，완선전가자순제도，가이개진약품심평능력。통과제정약품심평정서규범，건구우선심평정서，완선구통교류궤제，각수약품심평시한，가이간화화우화행정정서。미래응주의약품심평기술지도원칙국제화여본토화적결합，제정괄합중국실제수요적약품기술심평지도원칙。《화학약품CTD 격식신보자료찬사요구》적반포，철현료전구행정법급약품심평국제화적추세。
Being as the illustration of administrative license, the drug review is an important prior regulation method. For enhancing the drug review ability, much should be done in many fields including the construction of administrative governance network, the clariifcation of relationship between government organs and technical review institutions, the capacity building strengthen of the drug evaluation center of CFDA, appropriate allocation between central and local powers, and the improvement of expert consultation procedure. Moreover, through the formulation of drug review procedure standard, the construction of priority review procedure, and perfection of communication mechanism, as well as the abidance of drug review time limitation, the administrative procedure can be simpliifed and optimized. In future, the combination of global and local technical guidelines for drug review should be paid more attention in order to make up one suitable for China’s practical requirement. The release of the Declared Data Writing Requirement of Chemicals in CTD Format highlights the trends of global administrative law and drug review internationalization.
