中新网11月22日电 据国家食品药品监督管理局网站消息，为做好仿制药质量一致性评价，国家食品药品监督管理局药品注册司组织制定了《仿制药质量一致性评价工作方案(征求意见稿)》，向社会公开征求意见。以下为征求意见稿全文：

Beijing on November 22 (xinhua) -- according to the state food and drug administration website news,To make generics quality consistency evaluation,State food and drug administration organization established drug registration division[Generics quality consistency evaluation scheme(draft)],To the public to solicit their opinions.The following is the full text draft:

仿制药质量一致性评价工作方案(征求意见稿) Generics quality consistency evaluation scheme(draft)

　　仿制药是与被仿制药具有相同的活性成分、剂型、给药途径和治疗作用的替代药品，具有降低医疗支出，提高药品可及性，提升医疗服务水平等重要经济和社会效益。由于早期批准的仿制药医药学研究基础相对薄弱，部分仿制药质量与被仿制药差距较大，尚不能达到被仿制药的临床疗效，提高仿制药质量对维护公众健康意义重大。《国家药品安全“十二五”规划》明确提出要用5～10年时间，对2007年修订的《药品注册管理办法》实施前的仿制药，分期分批与被仿制药进行全面比对研究，使仿制药与被仿制药达到一致。为落实《国家药品安全“十二五”规划》有关要求，特制定本工作方案。

Generics are and be generics have the same active ingredient/Dosage form/Route of administration and treatment effect of alternative medicine,With lower medical expenditure,Improve the drug accessibility,Improve the medical service level and other important economic and social benefits.Because the early approved generics medicine research foundation relatively weak,Part of the generics quality and to be generics large gap,Is not to be generics clinical curative effect,To improve the quality of generic drugs to protect public health is of great significance.[The national drug safety"1025"planning]Clearly puts forward to want to use 5 ~ 10 years,For the 2007 revised[Measures for the administration of drug registration]Prior to the implementation of generics,By instalments and be generics to conduct a comprehensive comparison research,Make generics and be generics to achieve consistently.For the implementation of[The national drug safety"1025"planning]Relevant requirements,The work plan is formulated.

一、工作目标 a/Work target

　　仿制药质量一致性评价是国家食品药品监督管理部门组织相关技术部门及专家，对药品生产企业提出的仿制药自我评估资料，按照给定的评价方法和标准，评价其是否与被仿制药在内在物质和临床疗效上具有一致性的过程。通过仿制药质量一致性评价，要淘汰内在质量达不到要求的品种，促进我国仿制药整体水平提升，达到或接近国际先进水平。

Generics quality consistency evaluation is the national food and drug supervision and administration department organization related technical departments and experts,A pharmaceutical production enterprise to put forward generics self-assessment material,According to the given evaluation method and standard,Whether the evaluation and generics in material and clinical curative effect, with the process of consistency.Through the generics quality consistency evaluation,To out inner quality can not reach the requirements of the breed,Promote the overall level of ascension generics,Reach or approach the international advanced level.

二、工作方法 two/Working methods

　　(一)先试点、后推开，逐步推进。选择基本药物目录中用药人群广、市场销量大、生产企业多并且有明确原研企业的品种先行先试，积累经验，然后逐步推开，全面推进，逐步完善仿制药质量评价体系，构建药品质量持续提高的工作机制。

(a)The first pilot/Push away after,Gradually advance the.Choose essential drugs list drugs widely crowd/Market sales of large/Production enterprise more and have clear branded enterprise varieties first try first,Accumulate experience,Then gradually pushed,Comprehensively promote,Gradually improve generics quality evaluation system,Constructing the drug quality continuous improvement work mechanism.

　　(二)以科学合理的技术方法进行分类处理。本着科学合理、分类开展的原则，将仿制药质量一致性评价工作，与药品标准提高、评价性抽验工作相结合，并根据药物自身性质和药物剂型特点分类别、分剂型分步实施。首先开展口服固体制剂的一致性评价；其次开展注射剂的一致性评价；最后开展其他剂型的一致性评价。

(two)With scientific and reasonable technical method classification processing.In line with the scientific and reasonable/The principle of classification to carry out,Will generics quality consistency evaluation work,And drug standards to improve/Sample evaluation work should be combined,And according to their own nature and drug dosage form drug characteristics classification don't/Points dosage form implement step by step.First carry out of oral solid preparation of consistency evaluation;Secondly in the consistency of the injection evaluation;Finally to carry out other dosage forms of consistency evaluation.

三、工作职责 three/Job responsibilities

　　(一)国家食品药品监督管理局负责仿制药质量一致性评价工作的组织实施。组织制定仿制药质量一致性评价工作方案，发布相关评价方法、标准和技术指导原则，组织对药品生产企业提交的一致性评价资料进行审查。国家食品药品监督管理局将成立专项办公室具体负责此项工作。

(a)The state food and drug administration shall be responsible for the generics quality consistency evaluation work the organization to implement.Organizing the formulation of generics quality consistency evaluation scheme,Release relevant evaluation method/Standard and technical guiding principle,The organization to pharmaceutical production enterprises to present the evaluation data consistency examination.State food and drug administration will establish special office responsible for the specific work.

　　(二)省级药品监督管理部门负责辖区内仿制药质量一致性评价工作的组织和协调。承担仿制药质量一致性评价的实施和宣传，督促辖区内药品检验机构按时完成承担的各项任务，按照一致性评价工作部署配合做好相关培训，按照要求做好一致性评价资料的受理、生产现场检查和抽样检验等工作。

(two)Provincial pharmaceutical supervisory and administrative departments shall be responsible for within the jurisdiction of generics quality consistency evaluation of the organization and coordination.Bear generics quality consistency evaluation of implementation and propaganda,Supervise and urge the pharmaceutical inspection institutions within their respective jurisdictions completed on time for each task,According to the consistency evaluation work deployment fit well related training,According to the request and well consistency evaluation material acceptance/Production on-site inspection and sampling inspection, etc.

　　(三)药品生产企业是开展仿制药质量一致性评价的主体。应按照国家食品药品监督管理局的统一部署，根据有关技术指导原则、评价方法和标准，全面深入开展与被仿制药的对比研究，解决影响仿制药内在质量的关键问题，实现与被仿制药在内在物质和临床疗效方面的一致。

(three)Pharmaceutical producing enterprises is to carry out generics quality consistency evaluation main body.Should be in accordance with the state food and drug supervision and administration of the unified deployment,According to relevant technical guiding principle/Evaluation method and standard,Comprehensive and in-depth development of the comparison of the generics,Solve influence generics inner quality of key problems,Achieve and be generics in material and clinical curative effect, the consistent.

　　参比制剂生产企业应按国家食品药品监督管理局要求，配合做好评价方法和标准的起草，以及参比制剂的供应等工作。

Reference preparation production enterprise shall be according to the food and drug administration required,Cooperate the related evaluation method and standard drafting,And the reference preparation supply, etc.