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（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。
7、Pharmaceutical excipient manufacturers must guarantee the product quality and carry out full test on every batch according to the registered approved standardsor quality specification agreed with the drug manufacturers. Excipients can be arranged for warehousing and sold after passing all tests. Excipients must meet the requirements of national drug standards if applicable. The product can be released if it meets requirements after being examined by quality management department in terms of production file, records and test results. Products that can’t meet the requirements can’t be released.
（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。
8、Excipient manufacturers should coordinate with the drug manufacturers to carry out the supplier audits. For changes that have possible impact on the excipient quality such as process flow, raw materials, excipient manufacturers should carry out related study and evaluation, and inform the drug manufacturers in time.
（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。
10、Strict requirements are implemented for pharmaceutical excipients during the drug registration. Drug manufacturers should submit the pharmaceutical excipients information, suppliers, specification and supplier audit results etc when applying drug registration. For the supplementary application that needs to change the pharmaceutical excipient, relevant research should be carried out. Submit the research results and the supplier audit results to SFDA. The changed excipient can be use after approved by SFDA. For the supplementary application that only change the excipient supplier not the kind of excipient, relevant research should be carried out. The excipient from the new supplier can be used after submitting the research results and the supplier audit results to provincial FDA for file.
五、注重基础数据建设，建立诚信管理机制
Ⅴ、Emphasize the infrastructure construction and build trustmanagement 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、Establish database for pharmaceutical excipients. Drug manufacturers should
provide information about excipients that are using according to using status approved by drug supervision management division, inform and assist excipient manufacturers to provide production information of the excipients to local FDA. SFDA and provincial FDA will summarize relevant information and establish database of pharmaceutical excipients to know better about the production and use of excipients.
（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 credit file of excipient manufacturers. Provincial FDA should establish credit file of excipient manufacturers and publish inspection and random inspection status for drug manufacturers’ reference.
Regulations of strenthening the supervision on pharmaceutical excipients
- Publisher：
- Publication：2012/8/14
加强药用辅料监督管理的有关规定
Regulations of strengthening the supervision management
on pharmaceutical excipients
on pharmaceutical excipients
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：
一、药品制剂生产企业必须保证购入药用辅料的质量
I、Drug manufacturers must guarantee the quality of pharmaceutical excipients they purchase.
（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。
1、Drug manufacturers are the responsible organizations for the drug quality and must strength the production quality management to guarantee the safety of the drug quality. Drug manufacturers must pay high attention to the use and management of pharmaceutical excipients and use pharmaceutical excipients which meet related requirements to produce drugs according to the process flow approved by pharmaceutical supervision management division. For any drug quality issues resulted from the illegal acts in using pharmaceutical excipients,drug manufacturers must take the main responsibilities.
（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。
2、Drug manufacturers must improve the quality management system to make sure that the quality department can perform the duties for quality assurance and quality control effectively. The leader of the company and other people from department other than quality shall not interfere or hinder quality people to perform their duties. Selection of excipient suppliers should based on suppliers audit and approval of the quality department.
（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。
3、Drug manufacturers should reinforce the audit to pharmaceutical excipient suppliers. Evaluate the quality of the pharmaceutical excipient manufacturer periodically according to GMP. Carry out quality audit and review analysis to the pharmaceutical excipient manufacturers and set up quality files for the pharmaceutical excipient suppliers.
（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。
4、Drug manufacturers must control the quality of the pharmaceutical excipients applied strictly. All the pharmaceutical excipients should be tested according to the approved registered drug standards to ensure the compliance of pharmaceutical requirements. For the excipients that have national drug standards, the pharmaceutical excipients must meet 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。
5、Drug manufacturers should sign quality agreements with the main pharmaceutical excipient suppliers and know the changes status of the excipients applied at any time. Study and evaluate the impact of the changes on the drug quality and apply to SFDA according to DRUG REGISTRATION REGULATION.
二、药用辅料生产企业必须保证产品的质量
II、Manufacturers of pharmaceutical excipients must guarantee the quality of the products.
（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。
6、Manufacturers of pharmaceutical excipients must be responsible for the product quality and implement the Good manufacturing practice for pharmaceutical excipients strictly. Improve the quality management system, strengthen the audit to the raw material suppliers and control the quality of the raw materials strictly. Produce the product according to the registered approved process flow and regulate the batch definition to ensure the quality stability of the product. Excipients that don’t have the product licence but have been used for a long time should be produced according to the quality agreements between excipient manufacturers and pharmaceutical companies.
6、Manufacturers of pharmaceutical excipients must be responsible for the product quality and implement the Good manufacturing practice for pharmaceutical excipients strictly. Improve the quality management system, strengthen the audit to the raw material suppliers and control the quality of the raw materials strictly. Produce the product according to the registered approved process flow and regulate the batch definition to ensure the quality stability of the product. Excipients that don’t have the product licence but have been used for a long time should be produced according to the quality agreements between excipient manufacturers and pharmaceutical companies.
（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。
7、Pharmaceutical excipient manufacturers must guarantee the product quality and carry out full test on every batch according to the registered approved standardsor quality specification agreed with the drug manufacturers. Excipients can be arranged for warehousing and sold after passing all tests. Excipients must meet the requirements of national drug standards if applicable. The product can be released if it meets requirements after being examined by quality management department in terms of production file, records and test results. Products that can’t meet the requirements can’t be released.
（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。
8、Excipient manufacturers should coordinate with the drug manufacturers to carry out the supplier audits. For changes that have possible impact on the excipient quality such as process flow, raw materials, excipient manufacturers should carry out related study and evaluation, and inform the drug manufacturers in time.
三、药品监督管理部门对药用辅料实施分类管理
Ⅲ、Implementation of classification management onpharmaceutical excipients.
Ⅲ、Implementation of classification management onpharmaceutical excipients.
（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。
9、Classification management on pharmaceutical excipients will be implemented. For new pharmaceutical excipients and excipients with high safety risk, license management will be implemented which means the manufacturer must obtain the pharmaceutical production license and the product must obtain registration approval license. For other excipients, filing management will be implemented which means that the manufacturer and the product should be on file. The list of excipients required license management will be drawn up and published by SFDA.
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 excipients required license management, the manufacturers should submit related documents. Provincial FDA will organize on site inspection, dynamic sampling test according to Good Manufacturing Practices for pharmaceutical excipients. SFDA will issue license after evaluation and if the evaluation passes. SFDA will link the excipients with related pharmaceutical preparations when carrying out the evaluation.
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。
For excipients required filing management, the manufacturers submit related documents to provincial FDA. Provincial FDA will arrange on site inspection and sampling test accordingly.
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。
Relevant requirements for the license and filing management is formulated separately. Import pharmaceutical excipients also follow this regulation and submit documents to SFDA to apply license or be on file.
9、Classification management on pharmaceutical excipients will be implemented. For new pharmaceutical excipients and excipients with high safety risk, license management will be implemented which means the manufacturer must obtain the pharmaceutical production license and the product must obtain registration approval license. For other excipients, filing management will be implemented which means that the manufacturer and the product should be on file. The list of excipients required license management will be drawn up and published by SFDA.
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 excipients required license management, the manufacturers should submit related documents. Provincial FDA will organize on site inspection, dynamic sampling test according to Good Manufacturing Practices for pharmaceutical excipients. SFDA will issue license after evaluation and if the evaluation passes. SFDA will link the excipients with related pharmaceutical preparations when carrying out the evaluation.
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。
For excipients required filing management, the manufacturers submit related documents to provincial FDA. Provincial FDA will arrange on site inspection and sampling test accordingly.
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。
Relevant requirements for the license and filing management is formulated separately. Import pharmaceutical excipients also follow this regulation and submit documents to SFDA to apply license or be on file.
（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。
10、Strict requirements are implemented for pharmaceutical excipients during the drug registration. Drug manufacturers should submit the pharmaceutical excipients information, suppliers, specification and supplier audit results etc when applying drug registration. For the supplementary application that needs to change the pharmaceutical excipient, relevant research should be carried out. Submit the research results and the supplier audit results to SFDA. The changed excipient can be use after approved by SFDA. For the supplementary application that only change the excipient supplier not the kind of excipient, relevant research should be carried out. The excipient from the new supplier can be used after submitting the research results and the supplier audit results to provincial FDA for file.
（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 the standard management for pharmaceutical excipients. SFDA organizes Chinese Pharmacopiea Commission to carry out the standard development and revision, to publish national drug standards, to study and set up the recommended standards for pharmaceutical excipient. FDA of all levels should carry out supervision inspection according to national drug standards.
11、Strengthen the standard management for pharmaceutical excipients. SFDA organizes Chinese Pharmacopiea Commission to carry out the standard development and revision, to publish national drug standards, to study and set up the recommended standards for pharmaceutical excipient. FDA of all levels should carry out supervision inspection according to national drug standards.
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
Ⅳ、Pharmaceutical supervision management division muststrengthen the supervision through the whole period ofproduction and use for pharmaceutical excipients.
Ⅳ、Pharmaceutical supervision management division muststrengthen the supervision through the whole period ofproduction and use for pharmaceutical excipients.
（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。
12、Local FDA should take and allocate the responsibilities for supervision. Strengthen the daily monitor to drug manufacturers within the administrative regions and focus the examination to check if the drug manufacturer produce drugs according to the approved process flow, if the drug manufacturer carry out audits to the excipient manufacturers, if the drug manufacturer carry out tests to pharmaceutical excipients according to relevant quality standards, if the drug manufacturer makes changes to excipients without approval and if the changes of excipient suppliers are on file accordingly.
12、Local FDA should take and allocate the responsibilities for supervision. Strengthen the daily monitor to drug manufacturers within the administrative regions and focus the examination to check if the drug manufacturer produce drugs according to the approved process flow, if the drug manufacturer carry out audits to the excipient manufacturers, if the drug manufacturer carry out tests to pharmaceutical excipients according to relevant quality standards, if the drug manufacturer makes changes to excipients without approval and if the changes of excipient suppliers are on file accordingly.
（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、Local FDA should strengthen the supervision on the production of pharmaceutical excipients. Carry out the daily supervision to the excipient manufacturers within the administrative regions. Carry out the extension inspection to the excipients manufacturers if some problems are found in the drug manufacturers. Focus the examination to check if the production of the pharmaceutical excipients meet the Good Manufacturing Practices for pharmaceutical excipients, if there are strict controls on the raw materials, if the production is carried out according to the approved or files process flow, if there are complete batch management system and test regulations for releasing. Drug manufacturers can’t use the excipients from the manufactures that refuse to accept the inspection.
13、Local FDA should strengthen the supervision on the production of pharmaceutical excipients. Carry out the daily supervision to the excipient manufacturers within the administrative regions. Carry out the extension inspection to the excipients manufacturers if some problems are found in the drug manufacturers. Focus the examination to check if the production of the pharmaceutical excipients meet the Good Manufacturing Practices for pharmaceutical excipients, if there are strict controls on the raw materials, if the production is carried out according to the approved or files process flow, if there are complete batch management system and test regulations for releasing. Drug manufacturers can’t use the excipients from the manufactures that refuse to accept the inspection.
（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、FDA of all levels should strengthen the random inspection supervision on excipient manufacturers. Define the focus of random inspection and specify the
range and requirements. Random inspection should include both excipient manufacturers and drug manufacturers. More effort should be taken to companies and organizations that were found problems during past inspections.
14、FDA of all levels should strengthen the random inspection supervision on excipient manufacturers. Define the focus of random inspection and specify the
range and requirements. Random inspection should include both excipient manufacturers and drug manufacturers. More effort should be taken to companies and organizations that were found problems during past inspections.
（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、FDA of all levels should increase the efforts to investigate. Companies and relevant responsible people of drug manufacturers or excipient manufacturers will be punished if there is any violation found during production and using of pharmaceutical excipients according to Drug Administrative Law of P.R.C. etc. Sever punishment will be implemented for serious cases. When an illegal act constitutes a crime, criminal responsibility shall be investigated in accordance with law.
15、FDA of all levels should increase the efforts to investigate. Companies and relevant responsible people of drug manufacturers or excipient manufacturers will be punished if there is any violation found during production and using of pharmaceutical excipients according to Drug Administrative Law of P.R.C. etc. Sever punishment will be implemented for serious cases. When an illegal act constitutes a crime, criminal responsibility shall be investigated in accordance with law.
五、注重基础数据建设，建立诚信管理机制
Ⅴ、Emphasize the infrastructure construction and build trustmanagement 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、Establish database for pharmaceutical excipients. Drug manufacturers should
provide information about excipients that are using according to using status approved by drug supervision management division, inform and assist excipient manufacturers to provide production information of the excipients to local FDA. SFDA and provincial FDA will summarize relevant information and establish database of pharmaceutical excipients to know better about the production and use of excipients.
（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 credit file of excipient manufacturers. Provincial FDA should establish credit file of excipient manufacturers and publish inspection and random inspection status for drug manufacturers’ 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 the public to participate in the supervision. Support the industry association, 3rd party and the public to supervise and report to relevant authority for illegal acts for the production and use of pharmaceutical excipients in order to maintain the quality safety of drugs and excipients together. Relevant association should strengthen industry self‐discipline and accelerate the industrial trust construction and classification management etc.
18、Encourage the public to participate in the supervision. Support the industry association, 3rd party and the public to supervise and report to relevant authority for illegal acts for the production and use of pharmaceutical excipients in order to maintain the quality safety of drugs and excipients together. Relevant association should strengthen industry self‐discipline and accelerate the industrial trust construction and classification management etc.
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。
The Requirements will come into effect as of February 1, 2013
The Requirements will come into effect as of February 1, 2013