国家食品药品监管局2日召开记者会，发布《加强药用辅料监督管理的有关规定》。这一规定针对铬超标胶囊事件暴露出的药用辅料生产和使用存在的问题，提高了药用辅料的准入门槛并规定了更为严格的监管措施。

The state food and drug supervision bureau 2, held a press conference，release《To strengthen the supervision and administration of pharmaceutical raw materials relevant provisions》。The regulations for chrome overweight capsule events exposed pharmaceutical excipients production and use the existing problems，Improve the pharmaceutical raw materials of admittance threshold and provides more strict regulatory measures。

　　药用辅料是指药品生产和调配处方时使用附形剂和附加剂。按剂型可分为溶液剂、片剂、胶囊剂、栓剂等；按用途可分为溶媒、增溶剂、黏合剂等。

Pharmaceutical raw materials is refers to the drug production and allocate for use with form agent and additional agent。According to the dosage form can be divided into solution agent、tablet、capsule、Suppositories, etc；According to use can be divided into solvent、Increase solvent、Binder etc。

　　国家食品药品监督管理局药品注册司司长张伟介绍，规定分别明确了药品生产企业、药用辅料生产企业以及药品监管部门三方面的责任，并设立了信息公开、延伸监管以及利用社会资源加强监管的工作机制，同时加大了对违法违规行为的打击力度。

The state food and drug administration drug registration division priests zhang wei is introduced，Provisions made clear the respectively pharmaceutical production enterprise、Pharmaceutical excipients production enterprise and drug regulators the responsibility of the three aspects，And the establishment of the information public、Extensions supervision and use of social resources to strengthen the work of supervision mechanism，At the same time increased illegal to be enforced。

　　根据规定，凡因违法违规使用药用辅料引发的药品质量问题，药品制剂生产企业必须承担主要责任。药品制剂生产企业必须保证购入药用辅料的质量，健全质量管理体系，加强药用辅料供应商审计，对所使用的药用辅料质量严格把关，与主要药用辅料供应商签订质量协议。

According to the regulation，Because every illegal use of the drug by pharmaceutical raw materials quality problems，Pharmaceutical preparations production enterprise must take the main responsibility。Pharmaceutical preparations production enterprise must guarantee the quality of medicinal materials purchased，Perfect quality management system，Strengthen pharmaceutical raw materials suppliers，For the use of pharmaceutical raw materials to strictly control quality，And the main pharmaceutical raw materials supplier quality agreement signed。

　　为落实药用辅料监管责任，强化全过程监管，规定提出，药品监管部门要对药用辅料实施分类管理，严格药品注册申报对药用辅料的要求，加强药用辅料标准管理。对新的药用辅料和安全风险较高的药用辅料实行许可管理，即生产企业应取得《药品生产许可证》，品种必须获得注册许可；对其他辅料实行备案管理，即生产企业及其产品进行备案。

To carry out the pharmaceutical raw materials regulatory responsibilities，Strengthen the entire process control，Put forward by the，Drug regulators to pharmaceutical excipients classified management，Strict drug registration to declare the requirements of pharmaceutical raw materials，Strengthen pharmaceutical excipients standard management。For new pharmaceutical raw materials and safety risk higher pharmaceutical raw materials through a licensing management，That is the production enterprise shall be obtained《Pharmaceutical production license》，Must be obtained a license varieties；For other supplementary materials and a filing management，That is the production enterprises and their product for the record。

　　张伟介绍，为便于监管部门全面掌握辅料的情况，减少监管盲区，监管部门将建立药用辅料数据库，全面掌握药用辅料生产、使用的动态情况；建立辅料生产企业信用档案，公开对药用辅料生产企业的检查、抽验情况，供药品制剂生产企业选用药用辅料时参考。

Introduced zhang wei，To facilitate supervision department a comprehensive grasp of the auxiliary materials，Reduce regulatory blind area，Regulators will establish pharmaceutical raw materials database，A comprehensive grasp pharmaceutical raw materials production、The dynamic situation of use；Establish accessories production enterprise credit files，Public to the pharmaceutical excipients production enterprise examination、Market situation，Pharmaceutical preparations for production companies choose pharmaceutical excipients reference。

　　规定还加大了对违法行为的震慑力度，要求对违法违规行为按照《药品管理法》和《国务院关于加强食品等产品安全监督管理的特别规定》进行处理。(记者 胡浩)

Provisions also stepped up efforts to deter illegal behavior，According to the requirement of illegal activities《The pharmaceutical administration law》and《The state council on strengthening the supervision and management of the safety of food and other products of special provisions》processing。(Reporter HuHao)