要“救火”问题胶囊　更应“防火”安全隐患 to“fire”Problems should be more capsule“Fire prevention”Safe hidden trouble
——国家食品药品监管局局长尹力解读《加强药用辅料监督管理的有关规定》 -the state food and drug supervision bureau chief YinLi interpretation《To strengthen the supervision and administration of pharmaceutical raw materials relevant provisions》

    新华社北京８月３日电（记者 胡浩）铬超标胶囊事件一度将监管部门推至舆论的风口浪尖，从要求企业自查，到展开抽验，从敦促问题产品下架、封存、召回，到督促销毁，监管部门奋力“救火”。履新伊始的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，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。

    Beijing, aug. 3（Reporter HuHao）Chromium overweight capsule events once the supervision department will be pushed to the media outlet wave，From the request enterprise self-examination，To snap out，Products from urged problem frame、seal、recalled，To urge destroyed，Supervision department struggled to“fire”。At the office of the state food and drug administration YinLi 3, in an interview with xinhua news agency said，After the problem，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。

    

    监管，不能有盲区 supervision，Can't have blind area

    记者：什么是药用辅料？为何要出台《加强药用辅料监督管理的有关规定》？目前我国对药用辅料的监管存在哪些问题？

    reporter：What is a pharmaceutical raw materials？Why should publish《To strengthen the supervision and administration of pharmaceutical raw materials relevant provisions》？At present our country to the supervision of the pharmaceutical raw materials which problems exist？

    尹力：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。如大家常用的阿司匹林片，一般由阿司匹林、淀粉、微晶纤维素等组成。其中，阿司匹林是活性成分，起解热镇痛的治疗作用，淀粉、微晶纤维素就是药用辅料。如果没有淀粉、微晶纤维素等辅料，我们是无法将阿司匹林做成片剂的，大家也无法使用阿司匹林进行治疗和预防疾病。

    YinLi：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。As we commonly used aspirin tablets，General by aspirin、starch、Microcrystalline cellulose etc。Among them，Aspirin is active component，Heat up the therapeutic effect of analgesia，starch、Microcrystalline cellulose is pharmaceutical raw materials。If no starch、Microcrystalline cellulose material, etc，We are unable to make the tablet will aspirin，You also can't use aspirin treatment and prevention of disease。

    我国药用辅料的起步和发展较晚，上个世纪７０年代以前，基本上没有开发和应用新的药用辅料，而且所生产的辅料质量不高、品种少，也没有专门的药用辅料生产厂家。改革开放以来，我国的药用辅料发展较快，药用辅料生产企业规模逐渐壮大，品种也逐步增加。

    The medicinal materials start and development of late，The last century before the 70 s，Basically no development and application of new pharmaceutical raw materials，And the production of material quality is not high、Few varieties of，No special pharmaceutical raw materials manufacturers。Since the reform and opening，The fast development of pharmaceutical raw materials in China，Pharmaceutical excipients production enterprise scale become stronger，Variety is increasing。

    我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，２００１年出台的《药品管理法》中对药用辅料的管理提出了一些明确的要求。２００６年，国家局又发布了《药用辅料生产质量管理规范》，作为推荐性标准供企业参照执行。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。比如，监管手段欠缺、标准不齐全、企业诚信守法意识不强等等。前不久发生的胶囊事件也暴露出了我国药用辅料生产和使用中存在的问题。

    Our country to pharmaceutical raw materials management also going through a gradually strengthened、The process of gradually standard，2001 years on the introduction of the《The pharmaceutical administration law》The management of pharmaceutical raw materials, puts forward some specific requirements。2006 years，GuoGuJu and released《The quality control standard for pharmaceutical raw materials production》，As a voluntary standards for enterprises to refer to。Although regulators made certain effort，But in pharmaceutical raw materials for the management of still exists some problems。For example，Regulating means lack、Standard is not complete、Enterprise credibility consciousness not strong, and so on。The incident occurred shortly before the capsule also exposed the China pharmaceutical raw materials production and use of the existing problems。

    监管不能有盲区。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》。

    Supervision cannot have blind area。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》。

    

    新规，推动药用辅料监管升级 The new rules，Promote pharmaceutical excipients supervision to upgrade

    记者：规定采取了哪些措施升级对药用辅料的管理？

    reporter：What are the regulations to take measures to upgrade the management of pharmaceutical raw materials？

    尹力：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。监管部门重点是管药品制剂生产企业，同时也要对药品辅料生产企业进行监管，要落实责任。总的来说，就是要把药用辅料的生产和使用也纳入我们的视野，实现药品生产供应链的全过程的监管。通过对胶囊事件反思，我们认为过去这是一个比较薄弱的环节。

    YinLi：The new rules include the following several aspects of the measures：One is to carry out supervision responsibilities，Emphasis on pharmaceutical production process regulation。Regulators is the key drug preparation production enterprise，At the same time also to drug accessories production enterprise supervision，To fully implement the responsibility。In general，Is the production and use of pharmaceutical raw materials also included in our field of vision，Realization of the whole supply chain drug production supervision。Through the capsule reflection events，We think the past this is a weak links。

    二是提高准入门槛。作为药品制剂的一部分，药用辅料质量的好坏将直接影响药品安全。规定将药用辅料参照原料药进行管理，加大了监管力度。如要求药用辅料生产企业按照《药用辅料生产质量管理规范》的要求组织生产，提高生产企业准入门槛；根据风险程度对辅料实行分类管理，对高风险辅料及生产企业实行严格的准入制度，加强风险控制；要求新药用辅料必须与药物制剂关联审评，强调药品生产企业对新辅料的检验审计责任，进一步严格了药品所用药用辅料的固定来源和技术要求等。

    Two is to improve the admittance threshold。As part of the pharmaceutical preparations，Pharmaceutical raw materials will directly influence the quality of drug safety。Provisions of the pharmaceutical excipients refer to apis to carry on the management，Increased supervision。Such as the pharmaceutical excipients production enterprise in accordance with the requirements《The quality control standard for pharmaceutical raw materials production》Organize the production requirements，Improve production enterprise admittance threshold；According to the risk degree of classification management of materials，To high-risk materials and production enterprise strict access rules，Strengthen risk control；New materials and with requirements must be drug preparation evaluation association，Emphasize the pharmaceutical production enterprise for new materials inspection audit responsibility，Further strict drug use of pharmaceutical raw materials and fixed source technology requirements, etc。

    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。数据库包括药品生产企业生产每一个药品所使用的辅料的名称、来源（生产厂家）、质量标准等信息。还可以检索某一种辅料应用到哪些药品的生产。通过掌握这些信息，方便各级药品监管部门进行日常监管和延伸监管。

    At the same time，To facilitate supervision department a comprehensive grasp of the auxiliary materials，GuoGuJu will establish pharmaceutical raw materials database。Database including pharmaceutical production enterprise production each drug use the name of the auxiliary materials、source（manufacturers）、Quality standards and other information。Also can search a certain materials applied to what drug manufacturing。Through the master these information，Convenient drug regulators at all levels in daily supervision and extension of supervision。

    

    行业，将被清理整肃 industry，Purge clear

    记者：这一规定的出台对药用辅料行业和整个制药行业将产生怎样的影响？

    reporter：The rulings of pharmaceutical raw materials industry and the pharmaceutical industry will have the effect of how？

    尹力：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：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。国家食品药品监管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。The state food and drug supervision bureau is organizing a pharmacopoeia commission for the further research on drug accessories standard system revision，Hope to 2015 edition pharmacopoeia and double，Up to 300 standard accessories。

    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。

    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。

    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。

    总之，规定对药用辅料行业的自律，规范自己的行为，明确质量责任，防范质量事故的发生都会起到警钟长鸣的启示作用。

    In short，Provisions of the pharmaceutical raw materials industry self-discipline，Regulate their own behavior，Clear quality responsibility，Prevent quality accident will be a alarm bells keep enlightenment function。