中国国家食品药品监督管理局局长尹力3日在接受新华社记者采访时表示，铬超标胶囊问题出现后，固然要采取积极措施“救火”，但更重要的是完善相关制度和规定，从源头“防火”。近日出台的《加强药用辅料监督管理的有关规定》正是“防火”的举措之一。

China's state food and drug administration YinLi 3, in an interview with xinhua news agency said，Chromium overweight capsule after problems，Is to take active measures“fire”，But more important is to perfect the related system and provisions，From the source“Fire prevention”。Recently on the《To strengthen the supervision and administration of pharmaceutical raw materials relevant provisions》It is“Fire prevention”One of the measures。

　　尹力说，根据《药品管理法》，药用辅料指生产药品和调配处方时使用的赋形剂和附加剂。通俗地讲，药用辅料是药品中除活性成分外的其他成分的总称。

YinLi said，According to《The pharmaceutical administration law》，Pharmaceutical excipients refer to the production of pharmaceuticals and allocate prescription use excipients and additives used。Generally speaking，Pharmaceutical raw materials are drugs in addition to the active ingredients of the floorboard of the other ingredients。

　　他表示，中国对药用辅料的管理也经历着一个逐步加强、逐步规范的过程。虽然监管部门做出了一定努力，但在药用辅料的管理上仍然存在着一些问题。前不久发生的胶囊事件也暴露出了中国药用辅料生产和使用中存在的问题。

He said，China pharmaceutical raw materials management also going through a gradually strengthened、The process of gradually standard。Although regulators made certain effort，But in pharmaceutical raw materials for the management of still exists some problems。The incident occurred shortly before the capsule revealed China pharmaceutical excipients production and use of the existing problems。

　　为进一步加强药用辅料的管理，堵塞药用辅料生产及使用管理过程中的漏洞，国家食品药品监管局起草了《加强药用辅料监督管理的有关规定》。

In order to further strengthen the management of pharmaceutical raw materials，Jam pharmaceutical raw materials used in the process of production and management of loopholes，The state food and drug supervision bureau drafted《To strengthen the supervision and administration of pharmaceutical raw materials relevant provisions》。

　　尹力介绍，新规主要包括以下几方面的措施：其一是落实监管责任，重点强调对药品生产全过程的监管。二是提高准入门槛。同时，为便于监管部门全面掌握辅料的情况，国家局将建立药用辅料数据库。

YinLi introduced，The new rules include the following several aspects of the measures：One is to carry out supervision responsibilities，Emphasis on pharmaceutical production process regulation。Two is to improve the admittance threshold。At the same time，To facilitate supervision department a comprehensive grasp of the auxiliary materials，GuoGuJu will establish pharmaceutical raw materials database。

　　尹力说，规定的出台，对药用辅料行业的从业行为有了更严厉的法规要求，明年2月1日实施将使行业进一步得到清理。

YinLi said，rulings，For pharmaceutical raw materials industry working behavior had tougher regulations，February 1 implementation will make industry further clear。

　　规定提高了药用辅料的标准和门槛。目前实行的2010年版的《中国药典》收载了132个辅料产品的标准，虽然比2005版的药典翻了一番，但仍然不能完全覆盖现在市场上的产品。国家局正在组织药典委员会进一步开展对药品辅料标准的制修订工作，希望能够2015版药典再翻一番，达到300个辅料标准。

Improve the regulation of pharmaceutical raw materials standard and threshold。Now use 2010 version《China pharmacopoeia》Posted by 132 accessories product standards，Although more than 2005 version of the pharmacopoeia doubled，But still can't completely covered now products on the market。GuoGuJu is organizing a pharmacopoeia commission further research on drugs accessories standard system revision，Hope to 2015 edition pharmacopoeia and double，Up to 300 standard accessories。

　　他表示，药用辅料生产企业准入门槛和辅料产品质量标准的提高，必然使一部分不合格、不规范的药用辅料生产企业退出市场，市场环境将得到净化，产业集中度将进一步得到提升，这有利于优势企业的脱颖而出。

He said，Pharmaceutical excipients production enterprise admittance threshold and the improvement of product quality standard accessories，Will make one of them is not qualified、Not standard pharmaceutical excipients production enterprise to withdraw from the market，Market environment will be purified，Industrial concentration will be further promoted，The advantage of the enterprise to stand out。

　　另一方面，药品制剂生产企业作为药品质量的责任人，将更加注重上游供应商的质量，也会自觉地去把好进口关，有利于提高药品质量。(记者 胡浩)

On the other hand，Pharmaceutical preparations production enterprise as the person responsible for the quality of drugs，Will pay more attention to the quality of the upstream suppliers，Also on own initiative will go to the good import shut，To improve the quality of pharmaceuticals。(Reporter HuHao)