中新网8月2日电 据国家食药监局网站消息，食药监局2日召开新闻发布会，发布《加强药用辅料监督管理的有关规定》(以下简称《规定》。《规定》明确，必须严格药用辅料使用的管理，按照药品监督管理部门核准的处方工艺，使用符合要求的药用辅料生产药品。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。

Beijing August 2, according to the national food, the administration's web site news，Food, the administration's 2, held a news conference，release《To strengthen the supervision and administration of pharmaceutical raw materials relevant provisions》(Hereinafter referred to as《provisions》。《provisions》clear，Must be strictly pharmaceutical raw materials use management，Drug supervision and administration department for approval in accordance with the prescriptions process，Use to meet the requirements of pharmaceutical excipients production of drugs。Because every illegal use of the drug by pharmaceutical raw materials quality problems，Pharmaceutical preparations production enterprise must take the main responsibility。

　　《规定》全文如下：

《provisions》The following is the text：

　　

加强药用辅料监督管理的有关规定 To strengthen the supervision and administration of pharmaceutical raw materials relevant provisions

　　药用辅料是药品的重要组成部分，直接影响药品的质量。为进一步加强药用辅料生产、使用的监管，确保药品质量安全，依据《中华人民共和国药品管理法》及其实施条例、《国务院关于加强食品等产品安全监督管理的特别规定》、《药品生产监督管理办法》、《药品注册管理办法》、《药品生产质量管理规范》等相关法律法规规章，特规定如下：

Pharmaceutical raw materials is an important part of the drug，Directly affect the quality of the drugs。In order to further strengthen the pharmaceutical raw materials production、The supervision of the use，To ensure the quality and safety of drugs，According to《The pharmaceutical administration law of the People's Republic of China》And its implementation regulations、《The state council on strengthening the supervision and management of the safety of food and other products of special provisions》、《The supervision and administration of pharmaceutical production methods》、《Drug registration management approach》、《Standards for quality control of pharmaceutical production》Rules and regulations and other relevant laws，, the following provisions：

　　

一、药品制剂生产企业必须保证购入药用辅料的质量 a、Pharmaceutical preparations production enterprise must guarantee the quality of medicinal materials purchased

　　(一)药品制剂生产企业是药品质量责任人。必须切实加强药品生产质量管理，确保药品质量安全。必须严格药用辅料使用的管理，按照药品监督管理部门核准的处方工艺，使用符合要求的药用辅料生产药品。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。

(a)Pharmaceutical preparations production enterprise is drug quality responsibility。Must strengthen the quality control of pharmaceutical production，To ensure the quality and safety of drugs。Must be strictly pharmaceutical raw materials use management，Drug supervision and administration department for approval in accordance with the prescriptions process，Use to meet the requirements of pharmaceutical excipients production of drugs。Because every illegal use of the drug by pharmaceutical raw materials quality problems，Pharmaceutical preparations production enterprise must take the main responsibility。

　　(二)药品制剂生产企业必须健全质量管理体系。应确保质量管理部门有效履行质量保证和质量控制职责，企业负责人及其他部门人员不得干扰或妨碍质量管理部门履行职责。确定药用辅料供应商应进行审计并经企业质量管理部门批准。

(two)Pharmaceutical preparations production enterprise must perfect quality management system。Shall ensure that effective quality management department to perform quality assurance and quality control duties，The responsible person of the enterprise and other department personnel shall not interfere with or interfere with quality management department to perform the duties。Sure pharmaceutical raw materials supplier shall conduct audit and the enterprise quality management department for approval。

　　(三)药品制剂生产企业应加强药用辅料供应商审计。应按照《药品生产质量管理规范(2010年修订)》有关要求，对药用辅料生产企业定期进行质量评估，对药用辅料生产企业的质量体系进行质量审计和回顾分析，并建立所有购入药用辅料及供应商的质量档案。

(three)Pharmaceutical preparations production enterprises should strengthen pharmaceutical raw materials suppliers。Should according to《Standards for quality control of pharmaceutical production(Revised in 2010)》Relevant requirement，For pharmaceutical excipients production enterprise regular quality evaluation，For pharmaceutical raw materials production enterprise quality system audit and review the quality analysis，And establish all buy pharmaceutical raw materials and the quality of supplier file。

　　(四)药品制剂生产企业必须对所使用的药用辅料质量严格把关。凡购入的药用辅料，都必须按照药品批准注册时核准的质量标准进行检验，确保符合药用要求。对已颁布国家药品标准的药用辅料，必须符合国家药品标准的要求。

(four)Pharmaceutical preparations production enterprise to use of pharmaceutical raw materials to strictly control quality。Who purchased the pharmaceutical raw materials，Must be registered in accordance with the drug approval when the quality standard and test approved，To ensure compliance with the requirements for medicinal use。Issued by the national drug standards of the pharmaceutical raw materials，Must comply with the national drug standards。

　　(五)药品制剂生产企业应与主要药用辅料供应商签订质量协议。随时掌握所使用药用辅料的变更情况，研究和评估变更对药品质量的影响，并按照《药品注册管理办法》的要求进行申报。

(five)Pharmaceutical preparations should be the main production enterprise with pharmaceutical raw materials supplier quality agreement signed。To learn the use of pharmaceutical excipients changes，Research and evaluation of the influence of the drug quality changes，According to the《Drug registration management approach》Requirements to declare。

　　

二、药用辅料生产企业必须保证产品的质 two、Pharmaceutical excipients production enterprise must ensure that the product's quality量

quantity

　　(六)药用辅料生产企业必须对产品质量负责。应严格执行《药用辅料生产质量管理规范》，健全企业质量管理体系，加强对生产所用原材料的供应商审计，严格原材料质量控制，按照产品注册核准的处方工艺组织生产，规范产品批号的编制，保证产品质量稳定。对未取得批准文号且历史沿用的药用辅料，应按照与药品制剂生产企业合同约定的质量协议组织生产。

(six)Pharmaceutical excipients production enterprise must be responsible for the quality of products。Should strictly carry out《The quality control standard for pharmaceutical raw materials production》，Perfect enterprise quality management system，To strengthen the raw materials used in the production of suppliers，Strict quality control of raw materials，According to the product registration approved prescription organize production process，Standard product batch number of government，To guarantee the quality of the product is stable。Without obtaining a approval number and history used by pharmaceutical raw materials，Should according to and drug preparation production enterprise contract quality agreement organization production。

　　(七)药用辅料生产企业必须保证产品质量。应按注册批准的或与药品制剂生产企业合同约定的质量标准，对每批产品进行全项检验，合格后方可入库、销售。对已颁布国家药品标准的药用辅料，必须符合国家药品标准的有关要求。产品放行前，所有生产文件和记录，包括检验数据均应经质量管理部门审查并符合要求，不符合要求不得放行出厂。

(seven)Pharmaceutical excipients production enterprise must guarantee the quality of its products。According to the approved or registered shall be with drug preparation production enterprise contract quality standards，For each batch of products for the whole of inspection，Qualified rear can Treasury、sales。Issued by the national drug standards of the pharmaceutical raw materials，Must comply with the national drug standard the requirements。The product before release，All production documents and records，Including inspection data all should the quality management department to examine and comply with the requirements，Don't meet the requirements shall not release the factory。

　　(八)药用辅料生产企业应配合药品制剂生产企业开展供应商审计。若发生生产工艺、原材料来源等可能影响药用辅料质量的变更时，应主动开展相应的评估，及时通报药品制剂生产企业。

(eight)Pharmaceutical excipients production enterprise shall coordinate with production enterprises drug preparation supplier audit。If has the production process、Raw material source may affect the quality of the pharmaceutical excipients change，Should actively carry out the corresponding evaluation，Promptly inform drug preparation production enterprise。

　　

三、药品监督管理部门对药用辅料实施分类管理 three、Pharmaceutical supervisory and administrative department of pharmaceutical excipients classified management

　　(九)药用辅料实施分类管理。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。实行许可管理的品种目录由国家食品药品监督管理局组织制定，分批公布。

(nine)Pharmaceutical excipients classified 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。A licensing management breed directory by the state food and drug administration organizations to develop，Partial announced。

　　对实施许可管理的药用辅料，生产企业应按要求提交相关资料。经省级药品监督管理部门按照《药用辅料生产质量管理规范》的要求进行生产现场检查，动态抽样检验，并经国家食品药品监督管理局审核合格后，予以注册。国家食品药品监督管理局对辅料注册申请的审核应与相应的药物制剂进行关联。

For licensing management of pharmaceutical raw materials，Production enterprise shall submit the related data as required。The provincial level by the drug regulatory agency《The quality control standard for pharmaceutical raw materials production》Requirements for production spot checks，Dynamic sampling inspection，And by the state food and drug administration after qualified，Be registered。The food and drug administration to review the application for registration shall be complementary makings corresponding with the pharmaceutical preparations for the correlation。

　　对实施备案管理的药用辅料，由生产企业提交相关资料，报所在地省级药品监督管理部门备案。省级药品监督管理部门可根据需要进行现场检查和抽样检验。

The record of the implementation of the management of the pharmaceutical raw materials，By production enterprise submit relevant material，Quote local provincial pharmaceutical supervisory and administrative departments for the record。The pharmaceutical supervisory and administrative departments at the provincial level according to need to conduct site inspection and sampling inspection。

　　药用辅料许可及备案的相关要求另行制定。进口药用辅料参照此规定，报国家食品药品监督管理局许可或备案。

Pharmaceutical raw materials license and the relevant requirement of the record shall be formulated separately。With reference to the provisions of the import pharmaceutical raw materials，The state food and drug administration permission or for the record。

　　(十)严格药品注册申报对药用辅料的要求。药品制剂生产企业申报药品注册时，应提交所使用的药用辅料种类、供应商、质量标准及供应商审计结果等资料；对变更药用辅料种类的补充申请，应进行相应的研究，提交研究资料和供应商审计结果，报国家食品药品监督管理局审批后方可使用；对不改变辅料种类仅变更供应商的，需提交相应研究资料及供应商审计结果，向省级药品监督管理部门备案后方可使用。

(ten)Strict drug registration to declare the requirements of pharmaceutical raw materials。Pharmaceutical preparations production enterprise declare register drugs，Should submit the use of pharmaceutical raw materials species、suppliers、Quality standards and supplier audit results, and other material；To change pharmaceutical raw materials kinds of supplementary application，Should undertake the corresponding research，Submit research material and supplier audit results，The state food and drug administration approval rear can use；Don't change the types of materials only change of suppliers，Need to submit the relevant research material and supplier audit results，The provincial level to the pharmaceutical supervisory and administrative departments for the record rear can use。

　　(十一)加强药用辅料标准管理。国家食品药品监督管理局组织国家药典委员会开展药用辅料质量标准制修订工作，发布药用辅料国家药品标准，研究制定药用辅料推荐标准。各级药品监督管理部门依据国家药品标准进行监督检查。

(11)Strengthen pharmaceutical excipients standard management。The state food and drug administration organization state pharmacopoeia commission in pharmaceutical raw materials quality standard system revision，Release pharmaceutical raw materials the national drug standards，Study and establish pharmaceutical excipients recommend standard。The pharmaceutical supervisory and administrative departments at all levels, on the basis of the national drug standards for supervision and inspection。

　　

四、药品监督管理部门必须加强药用辅料生产使用全过程监管 four、Pharmaceutical supervisory and administrative departments must strengthen pharmaceutical excipients production use whole process control

　　(十二)地方各级药品监督管理部门应落实监管责任。要加强对本行政区域内药品制剂生产企业的日常监管，重点检查药品制剂生产企业是否按核准的工艺处方生产；是否按供应商审计的要求对药用辅料生产企业进行审计；是否按要求对所使用的药用辅料按相应质量标准进行检验；是否未经批准擅自变更药用辅料；供应商发生变化时是否按要求进行了备案等。

(twelve)The pharmaceutical supervisory and administrative departments of the local governments at various levels shall carry out supervision responsibilities。To strengthen the pharmaceutical preparation within their respective administrative areas of daily production enterprise supervision，Key check drug preparation production enterprise according to the approved process whether prescription production；According to supplier audit requirements whether to pharmaceutical excipients production enterprise for audit；Whether to use according to the requirements of pharmaceutical raw materials according to the corresponding quality standard and test；Whether without approval or alter pharmaceutical raw materials；Suppliers changes according to the requirements whether the record, etc。

　　(十三)地方各级药品监督管理部门应加强药用辅料生产监管。对本行政区域内药用辅料生产企业开展日常监督，或根据在药品制剂生产企业监督检查中发现的问题，对药用辅料生产企业进行延伸检查。重点检查药用辅料的生产是否符合《药用辅料生产质量管理规范》；是否严格控制原材料质量；是否按照核准或备案的工艺进行生产；是否建立完善的批号管理制度和出厂检验制度。对不接受检查的，药品制剂生产企业不得使用其生产的药用辅料。

(13)The pharmaceutical supervisory and administrative departments of the local governments at various levels shall strengthen the pharmaceutical excipients production supervision。Within their respective administrative regions pharmaceutical raw materials production enterprise in the daily routine supervision，According to the drug preparation or production enterprise supervision and inspection of the problems found in，For pharmaceutical excipients production enterprise for extensions inspection。Key check pharmaceutical raw materials production to qualify《The quality control standard for pharmaceutical raw materials production》；Whether strict control quality of raw material；In accordance with the approval or whether the record of the production process；Whether the batch number set up perfect management system and the factory inspection system。To not accept inspection，Pharmaceutical preparations production enterprise shall not use the production of pharmaceutical raw materials。

　　(十四)各级药品监督管理部门应加强对药用辅料的监督抽验。根据监督检查的情况，明确抽验重点，细化抽验范围和要求。抽验范围应涵盖药用辅料生产企业和药品制剂生产企业等药用辅料的使用单位。对以往监督检查和抽验中发现问题的企业和机构，要加大抽验频次和检查力度。

(14)The pharmaceutical supervisory and administrative departments at all levels should strengthen the supervision of the pharmaceutical raw materials from supermarkets。According to the supervision and inspection of the situation，Clear focus upon，The scope and refined from supermarkets requirements。Sample range should cover pharmaceutical raw materials production enterprise and drug agents such as production enterprise of pharmaceutical raw materials use the unit。The supervision and inspection of the past from supermarkets and found the problem enterprises and institutions，To increase the sample frequency and the inspection。

　　(十五)各级药品监督管理部门要加大查处力度。发现药品制剂生产企业、药用辅料生产企业在药用辅料生产、使用方面违法违规的，应按《中华人民共和国药品管理法》、《国务院关于加强食品等产品安全监督管理的特别规定》等有关规定对相关企业和责任人进行查处，情节严重的，依法从严从重处理。构成犯罪的，移送公安机关，依法追究刑事责任。

(15)The pharmaceutical supervisory and administrative departments at all levels should strengthen investigation dynamics。Find drug preparation production enterprise、Pharmaceutical excipients production enterprise in pharmaceutical raw materials production、Use of illegal，Should press《The pharmaceutical administration law of the People's Republic of China》、《The state council on strengthening the supervision and management of the safety of food and other products of special provisions》And other relevant provisions of related enterprise and responsible persons in the investigation，If the circumstances are serious，Severely deal with according to law。Constitute a crime，Transfer the case to the public security organ，Shall be investigated for criminal responsibility。

　　

五、注重基础数据建设，建立诚信管理机制 five、Pay attention to construction of basic data，The establishment of good faith management mechanism

　　(十六)建立药用辅料数据库。药品制剂生产企业应根据药品监督管理部门核准的药用辅料使用情况，填报在产品种的药用辅料使用信息，并通知和协助药用辅料生产企业填报药用辅料生产信息，报各自所在地省级药品监督管理部门。国家食品药品监督管理局和省级药品监督管理部门汇总相关信息，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。

(16)Establishing medicinal materials database。Pharmaceutical preparations should be based on the production enterprise drug supervision and administration department for approval of pharmaceutical raw materials used，In a given product of pharmaceutical raw materials use the information，And notice and assist pharmaceutical excipients production enterprise fill pharmaceutical excipients production information，Quote their local provincial drug supervision and administration department。The state food and drug administration and provincial drug supervision and administration department collect relevant information，Establishing medicinal materials database，A comprehensive grasp pharmaceutical raw materials production、The dynamic situation of use。

　　(十七)建立药用辅料生产企业信用档案。各省级药品监督管理部门应建立药用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。

(17)Establish pharmaceutical excipients production enterprise credit files。Each provincial pharmaceutical supervisory and administrative departments shall establish pharmaceutical excipients production enterprise credit files，Public to the pharmaceutical excipients production enterprise examination、Market situation，Pharmaceutical preparations for production companies choose pharmaceutical excipients reference。

　　(十八)鼓励社会公众参与监督管理。支持行业协会、第三方机构和公众对药用辅料生产使用过程中的违法违规行为进行监督和举报，共同维护药品及药用辅料质量安全。有关行业协会应当加强行业自律，推动行业诚信建设，推进分类管理，引导规范药品制剂生产企业和药用辅料生产企业诚信守法，依法经营。

(18)Encourage social public participation in supervision and management。Support industry association、The third party organizations and the public to pharmaceutical excipients production in the process of using illegal conduct supervision and reports，Common maintenance drugs and pharmaceutical raw materials quality safety。The relevant trade associations shall strengthen the self-discipline，Promote the industry to good faith construction，Classification management of，Drug preparation guide production enterprise and pharmaceutical excipients production enterprise credibility，Shall operate the。

　　本规定由国家食品药品监督管理局负责解释，自2013年2月1日起执行。

This regulations by the state food and drug administration shall be responsible for the explanation，Since the 2013 February 1 execution。