中新网11月15日电 据国家食品药品监管局网站消息，近日，国家食药监局批复同意了广东省先行先试药品审评审批机制的改革。

Beijing on November 15, according to the state food and drug supervision bureau website news,recently,National food, the administration's reply agreed to guangdong province first try to advance the reform of the mechanism of drug evaluation for examination and approval.

　　据悉，今年3月，为贯彻落实《珠江三角洲地区改革发展规划纲要(2008～2020年)》和《国务院关于横琴开发有关政策的批复》精神，在中共中央政治局委员、广东省委书记汪洋、省长朱小丹和国家食品药品监管局局长尹力的亲自关心支持下，广东省政府与国家食品药品监管局决定共同建设广东食品药品安全监管先行区，建立有利于食品药品监管机制改革创新在广东省先行先试的工作机制，研究出台相关扶持政策，并在广州签署了共同建设广东食品药品安全监管先行区合作备忘录。

It is reported,In march this year,In order to thoroughly implement the[The pearl river delta region plan for reform and development(2008 ~ 2020)]and[The state council on hengqin development of relevant policy reply]spirit,In the CCCPC political bureau &secretary of CPC/Guangdong provincial party committee secretary wang Yang/The governor ZhuXiaoDan and the state food and drug supervision bureau chief YinLi's personal care support,The government of guangdong province and the state food and drug supervision bureau decided to jointly build guangdong food and drug safety supervision anticipatory area,Set up to the food and drug supervision mechanism reform and innovation in guangdong province first try to advance the work mechanism,Research has issued relevant supporting policies,And in guangzhou signed the joint construction of guangdong food and drug safety supervision anticipatory area cooperation memorandum.

　　根据《广东省人民政府 国家食品药品监督管理局共同建设广东省食品药品安全监管先行区备忘录》，国家食品药品监管局于近日作出关于广东省先行先试药品审评审批机制改革的批复，同意与广东省共建药品审评机构，授权广东省食品药品监管局对行政区域内的新药技术转让、药品生产技术转让和部分跨省药品委托生产业务进行技术审评和行政审批。

According to[The people's government of guangdong province state food and drug administration jointly build guangdong food and drug safety supervision anticipatory area memo],State food and drug supervision bureau in guangdong province has made about first foretaste drug evaluation for examination and approval mechanism reform's reply,Agreed to build a drug evaluation institutions in guangdong province,Authorized guangdong food and drug supervision bureau of administrative area new drug technology transfer/Pharmaceutical production technology transfer and part of pharmaceutical production by entrustment across the province business technology evaluation and administrative examination and approval.

　　按照此次国家食品药品监管局的批复，广东省先行先试药品审评审批机制改革主要安排在三个方面。首先，国家食品药品监管局将与广东省共建药品审评机构，充分利用广东省药品审评工作资源，为不断深入推进药品审评审批机制改革提供新鲜经验。其次，授权广东省组织新药技术转让和药品生产技术转让申请的技术审评和行政审批。上述授权将涵盖形式审查、研制现场核查、生产现场检查、注册检验、技术审评、行政审批等工作内容。第三，授权广东省审批受托方为广东省内企业的药品委托生产。国家食品药品监管局将除生物制品和中药注射剂之外的跨省药品委托生产授权给广东省审批。

According to the state food and drug supervision bureau's reply,Guangdong province first foretaste drug evaluation for examination and approval mechanism reform main arrangement in three aspects.First of all,State food and drug supervision bureau of guangdong province will build a drug evaluation mechanism,Make full use of guangdong medicine review resources,To further promote a drug evaluation for examination and approval mechanism reform provide fresh experience.secondly,Guangdong province authorized organization new drug technology transfer and pharmaceutical production technology transfer application technology evaluation and administrative examination and approval.The above authorization will cover form review/Research field verification/Production on-site inspection/Registration inspection/Technology evaluation/Administrative examination and approval work content, etc.The third,Guangdong province authorized approval entrusted party for guangdong province enterprise of pharmaceutical production by entrustment.State food and drug supervision bureau will except biological products and traditional Chinese medicine injection across the province outside of pharmaceutical production by entrustment to guangdong province authorized for examination and approval.

　　广东省食品药品监管局主要负责人在会见中表示，将制定具体实施方案，报国家食品药品监管局批准后实施。今后在工作中，将加强对授权审评审批工作的管理，严格按有关规定进行审评审批，确保标准不降低、效率有提高。

Guangdong food and drug supervision bureau in a meeting with the principal said,Will formulate concrete implementation scheme,The state food and drug supervision bureau for approval.In the future work,Will strengthen the work of examination and approval for the evaluation of the authorized management,Strictly in accordance with the relevant provisions of the evaluation for examination and approval,To ensure the standard does not reduce/Efficiency is improve.

　　未来3年，双方还将在共建工作机制和研究扶持政策、加强食品药品监管技术支撑体系建设、加强食品药品监管能力建设、推动食品医药产业转型升级和健康发展等方面开展合作，共同推进广东食品药品安全监管先行区建设任务落实。

The next three years,The two sides also will be in the build work mechanism and research support policy/Strengthen the food and drug supervision technology support system construction/Strengthen the food and drug regulatory ability construction/To promote the transformation and upgrading of food medicine industry and healthy development in cooperation,Promote guangdong food and drug safety supervision anticipatory area construction tasks implement.