关于我国仿制药质量一致性评价的研究及建议

Study report on generic drug quality equivalence assessment

2013年2月启动的仿制药质量一致性评价工作是国家食品药品监督管理总局(CFDA)为执行国家药品安全"十二五"规划而开展的一项重要工作。从启动至今,工作已经取得了一些进展,但仍存在忽视药品质量体系的重要性、缺乏法定参比制剂、将体外溶出作为主要评价方法等3大问题,若不能妥善解决,将无法达到"十二五"规划所设定的目标,也会给公众用药带来安全隐患,给我国政府在民生保障方面的声誉带来负面影响,使医疗制度改革更为困难。本报告根据我国国情,参考了国际上仿制药质量评价技术先进国家的做法,提出了解决2个问题的2项具体建议:1与国家修改《药品管理法》修订工作并轨,先完善目前的立法缺失,将相关重要概念定义(如参比制剂、仿制药)以及仿制药一致性评价的关键原则和要求规定在《药品管理法》中,其后修改评价工作的现行方案。2如上述最优路径难以落实,则由CFDA出台部门规章,逐步建立法定参比制剂体系,明确目前仿制药一致性评价工作的分步实施办法。上述改进路径将保证评价体系科学完整,它既可以保证我国百姓能用上安全有效且质量可控的原研及仿制药品,又将推动我国制药产业在国际化发展机遇中整体升级并最终占领国际市场。

The generic drug quality equivalence assessment project which started in February 2013 is a key project carried out by China Food and Drug Administration（ CFDA） to implement the National Program for Drug Safety for the Twelfth Five-Year-Plan Period（ the ＂Drug Safety Program＂）. This project has made some progress since its initiation. However,three major issues remain： the ignorance of drug quality system,the absence of reference listed drugs and using in vitro dissolution assessment as major method. If these issues cannot be resolved properly,the goals set forth in the Drug Safety Program will not be met,which will pose a hidden danger to the safe use of drugs by the public,and have a negative impact on the reputation of the Chinese government for protecting the people＇s livelihood,and also create difficulties for the medical system reform. This report provides two specific suggestions to solve these two issues based on China＇s circumstances with reference to the practices of the countries with advanced technologies for generic drug quality assessment： Firstly,we need to take the opportunity of the amendment to the Drug Administration Law to include in this law of the highest authority for drugs the definitions of important concepts for the generic drug（ e. g. the Reference Listed Drug and the generic drug） as well as the principles and specific requirements for the equivalency assessment. Then,we can amend the current plan for the equivalence assessment. Secondly,if it is hard to implement the above-mentiond optimal approach,CFDA should promulgate department rules to establish the reference listed drug system gradually and specify the step-by-step process of im-plementation of the current generic drug quality equivalence assessment. Only the products that pass all three rounds of equivalence assessment shall be considered equivalent to the reference listed drugs. The above-mentiond improved approach will ensure a scientific and complete assessment system at a lower cost,prevent repeated assessment and effectively avoid safety issues for generic drugs. The positive significance for adopting these suggested improvements is far-reaching as these improvements not only ensure the Chinese people can use safe and effective innovative and generic drugs with controllable quality,but also facilitate an overall upgrade of China＇s pharmaceutical industry with the current international development opportunities as well as a final domination of the international market.