KYB CHINA(2002年8月4日中华人民共和国国务院令第360号公布 根据2016年2月6日《国务院关于修改部分行政法规的决定》第一次修订 根据2019年3月2日《国务院关于修改部分行政法规的决定》第二次修订 根据2024年12月6日《国务院关于修改和废止部分行政法规的决定》第三次修订 2026年1月16日中华人民共和国国务院令第828号第四次修订)
(Promulgated by Decree No. 360 of the State Council of the People's Republic of China on August 4, 2002; first revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on February 6, 2016; second revision in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on March 2, 2019; third revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on December 6, 2024; fourth revision by Decree No. 828 of the State Council of the People's Republic of China on January 16, 2026)
总 则
General Provisions
根据《中华人民共和国药品管理法》(以下简称药品管理法)，制定本条例。
These Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law).
从事药品研制、生产、经营、使用和监督管理活动，应当坚持以人民健康为中心，遵循科学规律和伦理原则，全面防控风险。
Engaging in drug research, production, distribution, use, and supervision and management activities shall adhere to the principle of putting people's health first, follow scientific laws and ethical principles, and comprehensively prevent and control risks.
国家完善药品创新体系，支持以临床价值为导向的药品研制和创新，鼓励研究和创制新药，支持新药临床推广和使用；促进中药传承创新，充分发挥中药在预防、医疗和保健中的作用；促进仿制药研发创新，提升仿制药质量和疗效。
The State shall improve the drug innovation system, support drug research and innovation oriented by clinical value, encourage the research and creation of new drugs, and support the clinical promotion and use of new drugs; promote the inheritance and innovation of traditional Chinese medicine (TCM), fully leveraging the role of TCM in prevention, medical treatment, and health care; promote the research, development, and innovation of generic drugs, and improve the quality and efficacy of generic drugs.
县级以上人民政府承担药品监督管理职责的部门(以下称药品监督管理部门)负责药品监督管理工作。县级以上人民政府其他有关部门在各自职责范围内负责与药品有关的监督管理工作。
The departments of the people's governments at or above the county level responsible for drug supervision and management (hereinafter referred to as drug regulatory authorities) shall be responsible for drug supervision and management. Other relevant departments of the people's governments at or above the county level shall be responsible for supervision and management related to drugs within their respective duties.
国务院工业和信息化主管部门、国务院商务主管部门等按照职责分工，根据国民经济和社会发展规划、药品产业发展情况制定国家药品生产、流通等行业发展相关规划和产业政策，推动药品产业结构调整和技术创新，提升产业链韧性和安全水平，促进药品产业高质量发展。国务院药品监督管理部门配合国务院工业和信息化主管部门、国务院商务主管部门等，执行国家药品行业发展相关规划和产业政策。
The competent department of industry and information technology of the State Council, the competent department of commerce of the State Council, and others shall, according to their respective duties, formulate relevant plans and industrial policies for the development of the national drug production and distribution industries based on the national economic and social development plan and the development of the pharmaceutical industry, promote the structural adjustment and technological innovation of the pharmaceutical industry, enhance the resilience and safety level of the industrial chain, and promote the high-quality development of the pharmaceutical industry. The drug regulatory authority of the State Council shall cooperate with the competent department of industry and information technology of the State Council, the competent department of commerce of the State Council, and others in implementing relevant plans and industrial policies for the development of the national pharmaceutical industry.
药品研制和注册
Drug Research and Registration
从事药品研制活动，应当遵守药物非临床研究质量管理规范、药物临床试验质量管理规范，保证记录和数据真实、准确、完整和可追溯。
Engaging in drug research activities shall comply with the Good Laboratory Practice for Non-clinical Studies and the Good Clinical Practice, ensuring that records and data are true, accurate, complete, and traceable.
以申请药品注册为目的开展药物非临床安全性评价研究活动的，应当由经过资格认定的药物非临床安全性评价研究机构实施。申请药物非临床安全性评价研究机构资格认定应当向国务院药品监督管理部门提出申请，提交证明其符合药物非临床研究质量管理规范的资料。国务院药品监督管理部门应当组织开展审查，并自受理申请之日起20个工作日内作出决定。对符合规定条件的，准予许可并发给资格证书；对不符合规定条件的，不予许可并书面说明理由。
Those conducting non-clinical safety evaluation research activities for the purpose of applying for drug registration shall be implemented by institutions that have been qualified for non-clinical safety evaluation research. An application for qualification of a non-clinical safety evaluation research institution shall be submitted to the drug regulatory authority of the State Council, along with materials proving compliance with the Good Laboratory Practice for Non-clinical Studies. The drug regulatory authority of the State Council shall organize a review and make a decision within 20 working days from the date of accepting the application. If the conditions are met, a permit shall be granted and a qualification certificate issued; if not, the application shall be rejected with a written explanation.
药物非临床安全性评价研究机构资格证书有效期为5年。有效期届满，需要继续实施药物非临床安全性评价研究的，应当申请重新核发资格证书。
The validity period of the qualification certificate for non-clinical safety evaluation research institutions is 5 years. If it is necessary to continue conducting non-clinical safety evaluation research after the expiration, an application for reissuance of the qualification certificate shall be made.
药物临床试验申办者应当选择具备相应能力的药物临床试验机构和研究者，并履行受试者保护、临床试验用药品管理、临床试验数据管理、风险管理等责任。
The sponsor of a drug clinical trial shall select a drug clinical trial institution and investigators with corresponding capabilities, and fulfill responsibilities such as protection of subjects, management of drugs used in clinical trials, management of clinical trial data, and risk management.
临床试验用药品的制备，应当符合药品生产质量管理规范的有关要求。
The preparation of drugs used in clinical trials shall comply with the relevant requirements of the Good Manufacturing Practice for Drugs.
药物临床试验申办者、药物临床试验机构不得向受试者收取与临床试验有关的费用。
The sponsor of a drug clinical trial and the drug clinical trial institution shall not charge subjects any fees related to the clinical trial.
依照药品管理法第十九条第一款规定批准开展的药物临床试验变更申办者的，应当向国务院药品监督管理部门提出申请。国务院药品监督管理部门应当自受理申请之日起20个工作日内进行审查并作出决定。
If the sponsor of a drug clinical trial approved in accordance with the first paragraph of Article 19 of the Drug Administration Law is changed, an application shall be submitted to the drug regulatory authority of the State Council. The drug regulatory authority of the State Council shall conduct a review and make a decision within 20 working days from the date of accepting the application.
以申请药品注册为目的在境外开展药品研制活动的，应当遵守药品管理法、本条例等法律、法规、规章、标准和规范的有关规定；在境外取得的研究数据，符合国务院药品监督管理部门有关规定的，可以用于申请药品注册。
If drug research activities are conducted abroad for the purpose of applying for drug registration, they shall comply with the relevant provisions of the Drug Administration Law, these Regulations, and other laws, regulations, rules, standards, and specifications; research data obtained abroad may be used for drug registration applications if they meet the relevant provisions of the drug regulatory authority of the State Council.
以申请药品注册为目的进口研制或者检验所需的对照药品、样品的，应当经国务院药品监督管理部门批准；但是，药物临床试验批准证明文件载明的临床试验用药品可以凭批准证明文件进口。国务院药品监督管理部门应当自受理申请之日起20个工作日内进行审查并作出决定。
The import of reference drugs or samples for research or testing purposes for drug registration applications shall be approved by the drug regulatory authority of the State Council; however, drugs for clinical trials specified in the drug clinical trial approval certificate may be imported with the approval certificate. The drug regulatory authority of the State Council shall conduct a review and make a decision within 20 working days from the date of accepting the application.
研制化学仿制药应当按照国务院药品监督管理部门制定的技术要求，科学选择对照药品进行对比研究；有经国务院药品监督管理部门确定的参比制剂的，应当选择参比制剂作为对照药品进行对比研究。
When developing chemical generic drugs, comparative studies shall be conducted by scientifically selecting reference drugs in accordance with the technical requirements formulated by the drug regulatory authority of the State Council; if there is a reference drug determined by the drug regulatory authority of the State Council, it shall be selected as the reference drug for comparative studies.
研制中药应当以中医药理论为指导，根据中医药理论、中药人用经验、临床试验数据等综合评价中药的安全性、有效性。评价中药的有效性应当与其临床定位相适应，体现中药的特点。
The development of TCM shall be guided by TCM theory, and the safety and efficacy of TCM shall be comprehensively evaluated based on TCM theory, TCM human experience, clinical trial data, etc. The evaluation of the efficacy of TCM shall be compatible with its clinical positioning and reflect the characteristics of TCM.
研制、生产中药应当保障中药材来源、质量的稳定性和资源的可持续利用，避免对生态环境产生不利影响；涉及野生动物、植物的，应当符合国家有关规定。
The development and production of TCM shall ensure the stability of the source and quality of TCM materials and the sustainable use of resources, avoiding adverse impacts on the ecological environment; if involving wild animals or plants, the relevant state provisions shall be complied with.
对申请注册的药品，国务院药品监督管理部门依照药品管理法第二十五条规定进行审评审批。
For drugs applied for registration, the drug regulatory authority of the State Council shall conduct review and approval in accordance with Article 25 of the Drug Administration Law.
为支持以临床价值为导向的药品研制和创新，国务院药品监督管理部门可以对符合条件的药品注册申请采用突破性治疗药物程序、附条件批准程序、优先审评审批程序、特别审批程序等，加快药品上市。
To support drug research and innovation oriented by clinical value, the drug regulatory authority of the State Council may adopt procedures such as breakthrough therapy drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures for eligible drug registration applications to accelerate the marketing of drugs.
国务院药品监督管理部门建立健全符合中药特点的审评审批、检查检验和标准管理制度。
The drug regulatory authority of the State Council shall establish and improve a review and approval, inspection, and standard management system that conforms to the characteristics of TCM.
国务院药品监督管理部门在审批药品时，对化学原料药一并审评审批；符合条件的，对药品颁发药品注册证书，对化学原料药颁发化学原料药批准证书。仿制已注册药品使用的化学原料药的，也可以直接向国务院药品监督管理部门提出审评审批申请；符合条件的，颁发化学原料药批准证书。国务院药品监督管理部门在审评审批化学原料药时，对化学原料药的质量标准、生产工艺、标签一并核准。
When approving drugs, the drug regulatory authority of the State Council shall simultaneously review and approve the chemical active pharmaceutical ingredient (API); if conditions are met, a drug registration certificate shall be issued for the drug, and an API approval certificate shall be issued for the chemical API. Those who imitate the chemical API used in registered drugs may also directly submit an application for review and approval to the drug regulatory authority of the State Council; if conditions are met, an API approval certificate shall be issued. When reviewing and approving chemical APIs, the drug regulatory authority of the State Council shall simultaneously approve the quality standards, production processes, and labels of the chemical APIs.
转让药品注册证书、化学原料药批准证书的，应当向国务院药品监督管理部门提出申请。国务院药品监督管理部门应当自受理申请之日起20个工作日内进行审查并作出决定。
To transfer a drug registration certificate or an API approval certificate, an application shall be submitted to the drug regulatory authority of the State Council. The drug regulatory authority of the State Council shall conduct a review and make a decision within 20 working days from the date of accepting the application.
药品注册证书、化学原料药批准证书有效期为5年。有效期届满，需要继续上市的，应当申请再注册。
The validity period of a drug registration certificate and an API approval certificate is 5 years. If continued marketing is needed after expiration, a re-registration shall be applied for.
药品上市许可持有人、化学原料药生产企业应当向所在地省级人民政府药品监督管理部门申请再注册；药品上市许可持有人、化学原料药生产企业为境外企业的，应当向国务院药品监督管理部门申请再注册。
The drug marketing authorization holder and the chemical API manufacturer shall apply for re-registration to the drug regulatory authority of the provincial people's government where they are located; if the drug marketing authorization holder or the chemical API manufacturer is an overseas enterprise, they shall apply for re-registration to the drug regulatory authority of the State Council.
符合国务院药品监督管理部门规定的非处方药注册情形的，药品注册申请人可以直接提出非处方药注册申请。
If the drug registration applicant meets the registration conditions for non-prescription drugs as specified by the drug regulatory authority of the State Council, they may directly submit an application for non-prescription drug registration.
已注册的处方药，药品上市许可持有人认为适宜作为非处方药管理的，可以向国务院药品监督管理部门申请转换为非处方药。已注册的非处方药，药品上市许可持有人根据不良反应监测和上市后评价结果认为不适宜作为非处方药管理的，应当向国务院药品监督管理部门申请转换为处方药。国务院药品监督管理部门组织开展评价后认为符合要求的，决定将处方药转换为非处方药或者将非处方药转换为处方药，并向社会公告。
For registered prescription drugs, if the drug marketing authorization holder considers them suitable for management as non-prescription drugs, they may apply to the drug regulatory authority of the State Council for conversion to non-prescription drugs. For registered non-prescription drugs, if the drug marketing authorization holder, based on adverse reaction monitoring and post-marketing evaluation results, considers them unsuitable for management as non-prescription drugs, they shall apply to the drug regulatory authority of the State Council for conversion to prescription drugs. After organizing an evaluation and finding it meets the requirements, the drug regulatory authority of the State Council shall decide to convert prescription drugs to non-prescription drugs or non-prescription drugs to prescription drugs and announce it to the public.
国务院药品监督管理部门根据保障公众用药安全的需要，组织开展评价后可以决定将非处方药转换为处方药。
The drug regulatory authority of the State Council may, based on the need to ensure public drug safety, decide to convert non-prescription drugs to prescription drugs after organizing an evaluation.
国家推动提高药品标准，持续提升药品质量水平。
The State promotes the improvement of drug standards and continuously enhances the quality level of drugs.
经国务院药品监督管理部门核准的药品质量标准，为药品注册标准。药品注册标准应当符合《中华人民共和国药典》的通用技术要求，并且不得低于相应的国家药品标准。药品上市许可持有人应当根据国家药品标准的制定和修订情况，对药品注册标准进行评估，需要修订的，及时修订并按照国务院药品监督管理部门的规定提出变更申请或者进行备案、报告。
The drug quality standards approved by the drug regulatory authority of the State Council are the drug registration standards. Drug registration standards shall comply with the general technical requirements of the Pharmacopoeia of the People's Republic of China and shall not be lower than the corresponding national drug standards. The drug marketing authorization holder shall evaluate the drug registration standards based on the formulation and revision of national drug standards; if revision is needed, it shall be revised in a timely manner and a change application shall be submitted or recordation/reporting shall be made in accordance with the provisions of the drug regulatory authority of the State Council.
研制药品、申请药品注册应当使用国家药品标准品、对照品。没有国家药品标准品、对照品的，药品注册申请人应当向国务院药品监督管理部门设置或者指定的药品检验机构报送药品质量标准研究所使用的原料及相关技术资料，药品检验机构应当依法研制、标定国家药品标准品、对照品。
When developing drugs and applying for drug registration, national drug standard substances and reference substances shall be used. If there are no national drug standard substances or reference substances, the drug registration applicant shall submit the raw materials used in the study of drug quality standards and related technical materials to the drug testing institution established or designated by the drug regulatory authority of the State Council, and the drug testing institution shall develop and calibrate national drug standard substances and reference substances in accordance with the law.
国务院药品监督管理部门设置或者指定的药品检验机构应当加强国家药品标准品、对照品的研制能力，保障国家药品标准品、对照品的供应。
The drug testing institution established or designated by the drug regulatory authority of the State Council shall strengthen its ability to develop national drug standard substances and reference substances and ensure the supply of national drug standard substances and reference substances.
国家支持儿童用药品、罕见病治疗用药品的研制和创新。
The State supports the development and innovation of drugs for children and drugs for the treatment of rare diseases.
对儿童用药品新品种、采用新剂型或者新规格的儿童用药品、增加儿童适应症的药品，符合条件的，给予不超过2年的市场独占期。
For new varieties of drugs for children, drugs for children with new dosage forms or new specifications, and drugs with added pediatric indications, if conditions are met, a market exclusivity period of not more than 2 years shall be granted.
对符合条件的罕见病治疗用药品，药品上市许可持有人承诺保障药品供应的，给予不超过7年的市场独占期。药品上市许可持有人不履行保障药品供应承诺的，市场独占期终止。
For drugs for the treatment of rare diseases that meet the conditions, if the drug marketing authorization holder commits to ensuring the supply of the drug, a market exclusivity period of not more than 7 years shall be granted. If the drug marketing authorization holder fails to fulfill the commitment to ensure drug supply, the market exclusivity period shall terminate.
给予市场独占期的具体条件和办法，由国务院药品监督管理部门制定。
The specific conditions and methods for granting market exclusivity periods shall be formulated by the drug regulatory authority of the State Council.
国家对含有新型化学成份的药品以及符合条件的其他药品的上市许可持有人提交的自行取得且未披露的试验数据和其他数据实施保护，任何人不得对该未披露的试验数据和其他数据进行不正当的商业利用。
The State protects the test data and other data that are independently obtained and not disclosed by the drug marketing authorization holder of drugs containing new chemical entities and other eligible drugs, and no one shall make improper commercial use of such undisclosed test data and other data.
前款规定的数据的保护期限自药品注册之日起不超过6年。在保护期限内，其他申请人未经药品上市许可持有人同意，使用前款规定的数据申请药品注册的，不予许可；但是，其他申请人提交自行取得数据的除外。
The protection period for the data specified in the preceding paragraph shall not exceed 6 years from the date of drug registration. During the protection period, if another applicant uses the data specified in the preceding paragraph to apply for drug registration without the consent of the drug marketing authorization holder, the application shall not be approved; however, this does not apply if the other applicant submits data obtained independently.
除下列情形外，药品监督管理部门不得披露本条第一款规定的数据：
Except in the following circumstances, the drug regulatory authority shall not disclose the data specified in the first paragraph of this Article:
(一)公共利益需要；
(1) Required by the public interest;
(二)已采取措施确保该类数据不会被不正当地进行商业利用。
(2) Measures have been taken to ensure that such data will not be improperly commercially used.
本条第一款规定的数据的具体保护办法，由国务院药品监督管理部门制定。
The specific protection measures for the data specified in the first paragraph of this Article shall be formulated by the drug regulatory authority of the State Council.
药品上市许可持有人
Drug Marketing Authorization Holders
药品上市许可持有人应当建立健全药品质量保证体系，设立独立的质量管理部门，配备生产负责人、质量负责人、质量受权人。质量受权人应当独立履行药品上市放行职责。
The drug marketing authorization holder shall establish and improve a drug quality assurance system, set up an independent quality management department, and appoint a production manager, a quality manager, and an authorized person for quality. The authorized person for quality shall independently perform the duties of drug release for marketing.
药品上市许可持有人应当遵守药物警戒质量管理规范，建立健全药物警戒体系，对药品不良反应及其他与用药有关的有害反应进行监测，建立风险识别、评估和控制机制。药品经营企业、医疗机构应当配合药品上市许可持有人开展药物警戒工作。
The drug marketing authorization holder shall comply with the Good Pharmacovigilance Practice, establish and improve a pharmacovigilance system, monitor adverse drug reactions and other harmful reactions related to drug use, and establish mechanisms for risk identification, assessment, and control. Drug distributors and medical institutions shall cooperate with the drug marketing authorization holder in carrying out pharmacovigilance work.
药物警戒质量管理规范由国务院药品监督管理部门制定。
The Good Pharmacovigilance Practice shall be formulated by the drug regulatory authority of the State Council.
药品上市许可持有人为境外企业的，其依照药品管理法第三十八条规定指定的中国境内企业法人应当具备相应的质量管理能力和风险控制能力，设立相应的管理部门、配备相应的人员；被指定的中国境内企业法人的相关信息应当在药品说明书中载明。
If the drug marketing authorization holder is an overseas enterprise, the Chinese domestic enterprise legal person designated by it in accordance with Article 38 of the Drug Administration Law shall have corresponding quality management capabilities and risk control capabilities, establish corresponding management departments, and assign corresponding personnel; the relevant information of the designated Chinese domestic enterprise legal person shall be indicated in the drug instructions.
药品上市许可持有人应当按照国务院药品监督管理部门的规定，提供语音、大字、盲文或者电子等无障碍格式版本的药品标签、说明书，方便残疾人、老年人用药。
The drug marketing authorization holder shall, in accordance with the provisions of the drug regulatory authority of the State Council, provide drug labels and instructions in accessible formats such as voice, large print, Braille, or electronic versions to facilitate medication use by persons with disabilities and the elderly.
电子版本药品说明书内容应当与国务院药品监督管理部门核准的药品说明书内容一致，与纸质版本药品说明书具有同等效力；语音、盲文版本药品标签、说明书供参考。
The content of the electronic version of the drug instructions shall be consistent with the content of the drug instructions approved by the drug regulatory authority of the State Council and shall have the same effect as the paper version of the drug instructions; the voice and Braille versions of drug labels and instructions are for reference.
药品上市许可持有人应当全面评估、验证药品生产过程中的变更对药品安全性、有效性和质量可控性的影响，按照国务院药品监督管理部门的规定提出变更申请或者进行备案、报告。
The drug marketing authorization holder shall comprehensively evaluate and verify the impact of changes in the drug production process on the safety, efficacy, and quality controllability of the drug, and submit a change application or make recordation/reporting in accordance with the provisions of the drug regulatory authority of the State Council.
药品监督管理部门应当加强对药品生产过程中变更的监督管理，发现药品上市许可持有人已备案或者报告变更的评估、验证不足以证明该变更科学、合理、风险可控，或者发现药品上市许可持有人选择的变更管理类别不当的，应当责令其改正、采取相应的风险控制措施，并依法予以处理。
The drug regulatory authority shall strengthen the supervision and management of changes in the drug production process. If it finds that the evaluation and verification of changes that have been recorded or reported by the drug marketing authorization holder are insufficient to prove that the change is scientific, reasonable, and risk-controllable, or that the change management category selected by the drug marketing authorization holder is inappropriate, it shall order corrections, take corresponding risk control measures, and handle the matter in accordance with the law.
药品上市许可持有人应当持续考察已注册药品的质量、疗效和不良反应。
The drug marketing authorization holder shall continuously examine the quality, efficacy, and adverse reactions of registered drugs.
药品上市许可持有人应当对已注册药品定期开展上市后评价，对药品的风险和获益进行综合分析评估，根据上市后评价结果，采取修订说明书、提高质量标准、完善生产工艺、暂停生产和销售、实施药品召回、申请注销药品注册证书等措施。必要时，国务院药品监督管理部门可以责令药品上市许可持有人开展上市后评价或者直接组织开展上市后评价。
The drug marketing authorization holder shall conduct post-marketing evaluations of registered drugs on a regular basis, comprehensively analyze and assess the risks and benefits of the drug, and based on the results of the post-marketing evaluation, take measures such as revising the instructions, improving quality standards, perfecting production processes, suspending production and sales, implementing drug recalls, and applying for cancellation of the drug registration certificate. When necessary, the drug regulatory authority of the State Council may order the drug marketing authorization holder to conduct a post-marketing evaluation or directly organize a post-marketing evaluation.
药品上市许可持有人未按照规定持续考察已注册药品质量、疗效和不良反应，或者未按照国务院药品监督管理部门要求开展上市后评价的，药品注册证书有效期届满后不予再注册。
If the drug marketing authorization holder fails to continuously examine the quality, efficacy, and adverse reactions of registered drugs as required, or fails to conduct post-marketing evaluations as required by the drug regulatory authority of the State Council, the drug registration certificate shall not be re-registered after expiration.
中药饮片生产企业、中药配方颗粒生产企业履行药品上市许可持有人的相关义务，对中药饮片、中药配方颗粒生产、销售实行全过程管理，建立中药饮片、中药配方颗粒追溯体系，保证中药饮片、中药配方颗粒安全、有效、可追溯。
TCM decoction piece manufacturers and TCM formula granule manufacturers shall fulfill the relevant obligations of drug marketing authorization holders, implement whole-process management of the production and sale of TCM decoction pieces and TCM formula granules, establish a traceability system for TCM decoction pieces and TCM formula granules, and ensure that TCM decoction pieces and TCM formula granules are safe, effective, and traceable.
药 品 生 产
Drug Production
从事药品生产活动，应当向所在地省级人民政府药品监督管理部门提出申请，提交证明其符合药品管理法第四十二条规定条件的资料；从事疫苗生产活动，还应当提交证明其符合《中华人民共和国疫苗管理法》(以下简称疫苗管理法)第二十二条第三款规定条件的资料。省级人民政府药品监督管理部门应当组织开展审查，并自受理申请之日起30个工作日内作出决定。对符合规定条件的，准予许可并发给药品生产许可证；对不符合规定条件的，不予许可并书面说明理由。
To engage in drug production activities, an application shall be submitted to the drug regulatory authority of the provincial people's government where the applicant is located, along with materials proving compliance with the conditions specified in Article 42 of the Drug Administration Law; to engage in vaccine production activities, materials proving compliance with the conditions specified in the third paragraph of Article 22 of the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law) shall also be submitted. The drug regulatory authority of the provincial people's government shall organize a review and make a decision within 30 working days from the date of accepting the application. If the conditions are met, a permit shall be granted and a drug production license issued; if not, the application shall be rejected with a written explanation.
药品生产企业变更药品生产许可证许可事项的，应当向原发证部门提出申请。原发证部门应当自受理申请之日起15个工作日内进行审查并作出决定。
If a drug manufacturer changes the licensed items of the drug production license, it shall submit an application to the original issuing authority. The original issuing authority shall conduct a review and make a decision within 15 working days from the date of accepting the application.
药品生产许可证有效期为5年。有效期届满，需要继续生产药品的，应当申请重新核发药品生产许可证。
The validity period of a drug production license is 5 years. If it is necessary to continue producing drugs after expiration, an application for reissuance of the drug production license shall be made.
药品上市许可持有人自行生产药品的，应当取得药品生产许可证。
If a drug marketing authorization holder produces drugs by itself, it shall obtain a drug production license.
药品上市许可持有人委托生产药品的，应当委托符合条件的药品生产企业。药品上市许可持有人应当履行供应商审核、药品生产过程中的变更管理、药品上市放行等责任，对受托生产企业进行监督，保证药品生产全过程持续符合法定要求。受托生产企业应当按照药品生产质量管理规范组织生产，不得再次委托生产。
If a drug marketing authorization holder entrusts the production of drugs, it shall entrust a qualified drug manufacturer. The drug marketing authorization holder shall fulfill responsibilities such as supplier audit, change management during drug production, and drug release for marketing, and supervise the entrusted manufacturer to ensure that the entire drug production process continuously meets legal requirements. The entrusted manufacturer shall organize production in accordance with the Good Manufacturing Practice for Drugs and shall not entrust production to a third party.
血液制品、麻醉药品、精神药品、医疗用毒性药品、药品类易制毒化学品以及含有麻醉药品、精神药品、药品类易制毒化学品成份的药品不得委托生产；但是，国务院药品监督管理部门另有规定的除外。
Blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, drug-like precursor chemicals, and drugs containing narcotic drugs, psychotropic substances, or drug-like precursor chemicals shall not be entrusted for production; however, exceptions provided by the drug regulatory authority of the State Council shall prevail.
药品上市许可持有人确有需要的，可以委托符合条件的药品生产企业分段生产下列药品：
If a drug marketing authorization holder has a genuine need, it may entrust a qualified drug manufacturer to produce the following drugs in segments:
(一)生产工艺、设施设备有特殊要求的创新药；
(1) Innovative drugs with special requirements for production processes, facilities, and equipment;
(二)国务院有关部门提出的临床急需的药品、应对突发公共卫生事件急需的药品或者储备需要的药品；
(2) Drugs clinically urgently needed as proposed by relevant departments of the State Council, drugs urgently needed for responding to public health emergencies, or drugs needed for stockpiling;
(三)国务院药品监督管理部门规定的其他药品。
(3) Other drugs specified by the drug regulatory authority of the State Council.
药品上市许可持有人委托分段生产药品的，应当建立覆盖药品生产全过程和全部生产场地的统一质量保证体系，保证药品生产全过程持续符合法定要求。
If a drug marketing authorization holder entrusts the segmented production of drugs, it shall establish a unified quality assurance system covering the entire drug production process and all production sites, ensuring that the entire drug production process continuously meets legal requirements.
有下列情形之一，超出疫苗上市许可持有人生产能力的，经国务院药品监督管理部门批准，疫苗上市许可持有人可以委托符合条件的疫苗生产企业生产或者分段生产疫苗：
In any of the following circumstances, if the production capacity of the vaccine marketing authorization holder is exceeded, with the approval of the drug regulatory authority of the State Council, the vaccine marketing authorization holder may entrust a qualified vaccine manufacturer to produce or segmentally produce vaccines:
(一)生产多联多价疫苗；
(1) Producing combination vaccines;
(二)国务院有关部门提出疾病预防、控制急需或者储备需要；
(2) Urgent need for disease prevention, control, or stockpiling as proposed by relevant departments of the State Council;
(三)国务院药品监督管理部门规定的其他情形。
(3) Other circumstances specified by the drug regulatory authority of the State Council.
生产疫苗、血液制品等生物制品，应当按照规定采用信息化手段如实记录生产、检验过程中形成的所有数据。
When producing biological products such as vaccines and blood products, all data generated during the production and testing process shall be recorded using information technology means as required.
在中国境内上市的药品在境外生产的，其生产活动应当符合药品管理法、本条例等法律、法规、规章、标准和规范的有关要求。境外生产的药品在境内分包装的，药品上市许可持有人向国务院药品监督管理部门备案后，实施分包装的药品生产企业可以向药品经营企业、医疗机构销售其分包装的药品。
If drugs marketed in China are produced abroad, their production activities shall comply with the relevant requirements of the Drug Administration Law, these Regulations, and other laws, regulations, rules, standards, and specifications. If drugs produced abroad are repackaged in China, after the drug marketing authorization holder files a record with the drug regulatory authority of the State Council, the drug manufacturer implementing the repackaging may sell the repackaged drugs to drug distributors and medical institutions.
取得药品批准证明文件前生产的下列药品，符合药品上市放行要求的，在取得药品批准证明文件后，可以上市销售：
The following drugs produced before obtaining the drug approval certificate, if meeting the drug release requirements for marketing, may be marketed and sold after obtaining the drug approval certificate:
(一)通过相应药品生产质量管理规范符合性检查的商业规模批次产品；
(1) Commercial-scale batch products that have passed the corresponding Good Manufacturing Practice for Drugs compliance inspection;
(二)属于新药、罕见病治疗用药品、短缺药品以及其他临床急需的药品的，在通过相应药品生产质量管理规范符合性检查之后生产的商业规模批次产品。
(2) For new drugs, drugs for the treatment of rare diseases, shortage drugs, and other clinically urgently needed drugs, commercial-scale batch products produced after passing the corresponding Good Manufacturing Practice for Drugs compliance inspection.
药品上市许可持有人应当加强对依照前款规定上市销售药品的风险管理。
The drug marketing authorization holder shall strengthen the risk management of drugs marketed and sold in accordance with the preceding paragraph.
国家鼓励发展中药材规范化种植养殖，鼓励使用道地中药材。省级人民政府根据当地实际制定相关规划，鼓励实施中药材生产质量管理规范，推动中药材规范化种植养殖。
The State encourages the development of standardized cultivation and breeding of TCM materials and encourages the use of authentic TCM materials. Provincial people's governments shall formulate relevant plans based on local conditions, encourage the implementation of the Good Agricultural Practice for TCM Materials, and promote standardized cultivation and breeding of TCM materials.
根据中药材特点，可以对中药材进行产地加工。省级人民政府药品监督管理部门应当根据中药材生产质量管理规范，结合当地中药材资源分布、传统种植养殖历史和道地中药材特性等，制定中药材产地加工指导原则。
Based on the characteristics of TCM materials, primary processing may be carried out at the place of origin. The drug regulatory authority of the provincial people's government shall, in accordance with the Good Agricultural Practice for TCM Materials and considering local distribution of TCM material resources, traditional cultivation and breeding history, and characteristics of authentic TCM materials, formulate guiding principles for primary processing of TCM materials at the place of origin.
生产药品使用的中药材应当符合国家药品标准、药品注册标准。没有国家药品标准、药品注册标准的，应当符合省级人民政府药品监督管理部门制定的地区性民间习用药材标准。
TCM materials used in drug production shall comply with national drug standards or drug registration standards. If there are no national drug standards or drug registration standards, they shall comply with the regional folk medicinal material standards formulated by the drug regulatory authority of the provincial people's government.
首次进口中药材应当经国务院药品监督管理部门批准。国务院药品监督管理部门应当自受理申请之日起20个工作日内进行审查并作出决定。
The first import of TCM materials shall be approved by the drug regulatory authority of the State Council. The drug regulatory authority of the State Council shall conduct a review and make a decision within 20 working days from the date of accepting the application.
中药饮片生产企业应当自行炮制中药饮片，不得委托炮制中药饮片。
TCM decoction piece manufacturers shall process TCM decoction pieces by themselves and shall not entrust the processing of TCM decoction pieces.
中药饮片应当按照国家药品标准炮制；国家药品标准没有规定的，应当按照省级人民政府药品监督管理部门制定的炮制规范炮制。
TCM decoction pieces shall be processed in accordance with national drug standards; if national drug standards do not provide for them, they shall be processed in accordance with the processing specifications formulated by the drug regulatory authority of the provincial people's government.
按照省级人民政府药品监督管理部门制定的炮制规范炮制的中药饮片可以跨省级行政区域销售、使用。其中，炮制方法、用药特点存在地区性差异且易导致临床用药混淆的中药饮片跨省级行政区域销售的，中药饮片生产企业应当在中药饮片标签上标明临床用药提示信息并向购进、使用地省级人民政府药品监督管理部门备案；医疗机构应当加强采购管理和合理用药监测，防止临床用药混淆。具体办法由国务院药品监督管理部门制定。
TCM decoction pieces processed in accordance with the processing specifications formulated by the drug regulatory authority of the provincial people's government may be sold and used across provincial administrative regions. Among them, if TCM decoction pieces with regional differences in processing methods and medication characteristics that are prone to clinical medication confusion are sold across provincial administrative regions, the TCM decoction piece manufacturer shall indicate clinical medication caution information on the label of the TCM decoction pieces and file a record with the drug regulatory authority of the provincial people's government of the purchasing and using location; medical institutions shall strengthen procurement management and rational medication monitoring to prevent clinical medication confusion. Specific measures shall be formulated by the drug regulatory authority of the State Council.
中药饮片的标签应当注明产品属性、品名、规格、中药材产地、生产企业、产品批号、生产日期、装量、保质期、执行标准、贮藏条件等；实施审批管理的中药饮片，还应当注明药品批准文号。
The label of TCM decoction pieces shall indicate product attributes, product name, specification, place of origin of TCM materials, manufacturer, batch number, production date, fill quantity, shelf life, implementing standard, storage conditions, etc.; for TCM decoction pieces subject to approval management, the drug approval number shall also be indicated.
中药配方颗粒生产企业应当将所生产的中药配方颗粒品种向所在地省级人民政府药品监督管理部门备案。
TCM formula granule manufacturers shall file the varieties of TCM formula granules they produce with the drug regulatory authority of the provincial people's government where they are located.
中药配方颗粒生产企业应当自行炮制用于中药配方颗粒生产的中药饮片、自行生产中药配方颗粒，不得使用购进的中药饮片生产中药配方颗粒，不得委托生产中药配方颗粒。
TCM formula granule manufacturers shall process the TCM decoction pieces used for the production of TCM formula granules by themselves and produce TCM formula granules by themselves; they shall not use purchased TCM decoction pieces to produce TCM formula granules, nor entrust the production of TCM formula granules.
中药配方颗粒应当按照国家药品标准生产；国家药品标准没有规定的，应当按照省级人民政府药品监督管理部门制定的中药配方颗粒标准生产。
TCM formula granules shall be produced in accordance with national drug standards; if national drug standards do not provide for them, they shall be produced in accordance with the TCM formula granule standards formulated by the drug regulatory authority of the provincial people's government.
按照省级人民政府药品监督管理部门制定的中药配方颗粒标准生产的中药配方颗粒可以跨省级行政区域销售、使用；中药配方颗粒跨省级行政区域销售的，中药配方颗粒生产企业应当向购进、使用地省级人民政府药品监督管理部门备案。
TCM formula granules produced in accordance with the TCM formula granule standards formulated by the drug regulatory authority of the provincial people's government may be sold and used across provincial administrative regions; if TCM formula granules are sold across provincial administrative regions, the TCM formula granule manufacturer shall file a record with the drug regulatory authority of the provincial people's government of the purchasing and using location.
中药配方颗粒的标签应当注明品名、规格、生产企业、产品批号、生产日期、保质期、执行标准、贮藏条件、备案号等。
The label of TCM formula granules shall indicate product name, specification, manufacturer, batch number, production date, shelf life, implementing standard, storage conditions, record number, etc.
药品经营企业不得经营中药配方颗粒。
Drug distributors shall not deal in TCM formula granules.
从事辅料、直接接触药品的包装材料和容器生产活动，应当遵守药品生产质量管理规范的有关规定，建立健全生产质量管理体系，保证生产全过程持续符合法定要求。
Engaging in the production of excipients and packaging materials and containers that come into direct contact with drugs shall comply with the relevant provisions of the Good Manufacturing Practice for Drugs, establish and improve a production quality management system, and ensure that the entire production process continuously meets legal requirements.
禁止使用国家已淘汰的辅料、直接接触药品的包装材料和容器生产药品。
It is prohibited to use excipients, packaging materials, and containers that come into direct contact with drugs that have been eliminated by the State to produce drugs.
药 品 经 营
Drug Distribution
从事药品经营活动，应当向所在地县级以上地方人民政府药品监督管理部门提出申请，提交证明其符合药品管理法第五十二条规定条件的资料。县级以上地方人民政府药品监督管理部门应当组织开展审查，并自受理申请之日起20个工作日内作出决定。对符合规定条件的，准予许可并发给药品经营许可证；对不符合规定条件的，不予许可并书面说明理由。
To engage in drug distribution activities, an application shall be submitted to the local drug regulatory authority of the people's government at or above the county level, along with materials proving compliance with the conditions specified in Article 52 of the Drug Administration Law. The local drug regulatory authority of the people's government at or above the county level shall organize a review and make a decision within 20 working days from the date of accepting the application. If the conditions are met, a permit shall be granted and a drug distribution license issued; if not, the application shall be rejected with a written explanation.
药品经营企业变更药品经营许可证许可事项的，应当向原发证部门提出申请。原发证部门应当自受理申请之日起15个工作日内进行审查并作出决定。
If a drug distributor changes the licensed items of the drug distribution license, it shall submit an application to the original issuing authority. The original issuing authority shall conduct a review and make a decision within 15 working days from the date of accepting the application.
药品经营许可证有效期为5年。有效期届满，需要继续经营药品的，应当申请重新核发药品经营许可证。
The validity period of a drug distribution license is 5 years. If it is necessary to continue distributing drugs after expiration, an application for reissuance of the drug distribution license shall be made.
药品经营企业应当配备与其经营范围、规模相适应的依法经过资格认定的药师或者其他药学技术人员；但是，只经营乙类非处方药的药品零售企业，可以按照国务院药品监督管理部门的规定配备药学技术人员。
Drug distributors shall be equipped with pharmacists or other pharmaceutical technical personnel who have been legally qualified and are commensurate with their business scope and scale; however, drug retail enterprises that only deal in Class B over-the-counter drugs may be equipped with pharmaceutical technical personnel in accordance with the provisions of the drug regulatory authority of the State Council.
药品零售企业应当凭处方销售处方药。
Drug retail enterprises shall sell prescription drugs only with a prescription.
药品上市许可持有人、药品生产企业、药品经营企业储存、运输药品，应当根据药品的包装、质量特性、温度控制要求等采取有效措施，保证储存、运输过程中的药品质量。药品上市许可持有人、药品生产企业、药品经营企业委托储存、运输药品的，应当选择具备相应能力的受托方，并对受托方进行监督。受托方应当加强药品储存、运输过程管理，采取有效措施保证药品质量。
When storing and transporting drugs, drug marketing authorization holders, drug manufacturers, and drug distributors shall take effective measures based on the packaging, quality characteristics, temperature control requirements, etc. of the drugs to ensure the quality of drugs during storage and transportation. If drug marketing authorization holders, drug manufacturers, or drug distributors entrust the storage and transportation of drugs, they shall select atrustee with corresponding capabilities and supervise thetrustee. Thetrustee shall strengthen the management of drug storage and transportation processes and take effective measures to ensure drug quality.
药品零售企业向患者配送的药品应当有独立包装和显著标识。
Drugs delivered by drug retail enterprises to patients shall have independent packaging and prominent identification.
药品网络交易第三方平台提供者应当建立健全药品网络销售质量管理体系，设立相应的管理部门、配备药学技术人员等相关专业人员，制定并实施药品质量管理、配送管理等制度。药品网络交易第三方平台提供者应当对申请进入平台经营的药品上市许可持有人、药品经营企业的资质等进行审核，对平台展示的药品信息进行检查，对发生在平台的药品经营行为进行管理。药品网络交易第三方平台提供者应当按照规定保存审核、检查记录以及平台展示的药品信息。
Third-party platform providers for drug online transactions shall establish and improve a quality management system for online drug sales, set up corresponding management departments, equip pharmaceutical technical personnel and other relevant professionals, and formulate and implement systems for drug quality management, distribution management, etc. Third-party platform providers for drug online transactions shall review the qualifications of drug marketing authorization holders and drug distributors applying to enter the platform for business, inspect the drug information displayed on the platform, and manage the drug distribution activities occurring on the platform. Third-party platform providers for drug online transactions shall retain review and inspection records as well as drug information displayed on the platform in accordance with regulations.
药品网络交易第三方平台提供者、药品上市许可持有人、药品经营企业为其他药品网络交易第三方平台提供者、药品上市许可持有人、药品经营企业通过网络销售药品提供信息展示、链接跳转等服务的，应当遵守国务院药品监督管理部门的规定。
If third-party platform providers for drug online transactions, drug marketing authorization holders, or drug distributors provide services such as information display and link jumps for other third-party platform providers for drug online transactions, drug marketing authorization holders, or drug distributors selling drugs online, they shall comply with the provisions of the drug regulatory authority of the State Council.
疫苗、血液制品、麻醉药品、精神药品、医疗用毒性药品、放射性药品、药品类易制毒化学品等国家实行特殊管理的药品不得通过网络销售；其他用药风险较高的药品，不得通过网络零售。具体目录由国务院药品监督管理部门制定。
Vaccines, blood products, narcotic drugs, psychotropic substances, toxic drugs for medical use, radioactive drugs, drug-like precursor chemicals, and other drugs subject to special state management shall not be sold online; other drugs with higher medication risks shall not be retailed online. The specific catalog shall be formulated by the drug regulatory authority of the State Council.
对医疗机构提出的因临床急需进口少量药品的申请，国务院药品监督管理部门应当征求国务院卫生健康主管部门的意见，及时进行审查并作出决定。国务院授权省级人民政府实施审批的，被授权的省级人民政府应当结合当地实际制定具体审批办法。
For applications submitted by medical institutions for the import of a small quantity of drugs urgently needed for clinical use, the drug regulatory authority of the State Council shall solicit the opinions of the competent health department of the State Council and conduct a review and make a decision in a timely manner. If the State Council authorizes a provincial people's government to implement the approval, the authorized provincial people's government shall formulate specific approval measures based on local conditions.
个人携带、邮寄少量药品进境的，应当以合理自用数量为限，遵守国家关于个人物品进境管理的规定。
Individuals carrying or mailing a small quantity of drugs into the country shall be limited to a reasonable quantity for personal use and shall comply with the state regulations on the management of personal articles entering the country.
医疗机构药事管理
Pharmaceutical Affairs Management in Medical Institutions
医疗机构应当制定并实施药品进货检查验收、保管、使用等管理制度，设立相应的管理部门或者指定人员负责药品质量管理工作。
Medical institutions shall formulate and implement management systems for drug procurement inspection and acceptance, storage, and use, and set up corresponding management departments or designate personnel responsible for drug quality management.
医疗机构应当加强对处方开具、审核和调配的管理，提高医师合理用药水平。
Medical institutions shall strengthen the management of prescription writing, review, and dispensing, and improve the level of rational drug use by physicians.
医师在网络诊疗活动中不得开具本条例第四十六条规定的药品的处方。
Physicians shall not issue prescriptions for the drugs specified in Article 46 of these Regulations during online diagnosis and treatment activities.
医疗机构应当向患者提供符合国务院卫生健康主管部门规定的处方，患者可以选择凭处方向药品零售企业购买药品。
Medical institutions shall provide patients with prescriptions that comply with the provisions of the competent health department of the State Council, and patients may choose to purchase drugs from drug retail enterprises with the prescription.
鼓励通过信息化手段实现医疗机构和药品零售企业之间的处方流转。
The transfer of prescriptions between medical institutions and drug retail enterprises through information technology means is encouraged.
对正在开展临床试验的用于治疗严重危及生命且尚无有效治疗手段的疾病的药物，经医学观察可能获益，并且符合伦理原则的，经伦理委员会审查同意、患者或者其监护人签署知情同意书后，可以在开展临床试验的机构内用于其他病情相同但无法参加临床试验的患者。
For drugs under clinical trials that are used to treat diseases that are seriously life-threatening and for which there is no effective treatment, if medical observation indicates potential benefit and the ethical principles are met, with the review and approval of the ethics committee and the signing of informed consent by the patient or their guardian, they may be used within the institution conducting the clinical trial for other patients with the same condition who cannot participate in the clinical trial.
医疗机构配制制剂，应当向所在地省级人民政府药品监督管理部门提出申请，提交证明其符合药品管理法第七十五条第一款规定条件的资料。省级人民政府药品监督管理部门应当组织开展审查，并自受理申请之日起30个工作日内作出决定。对符合规定条件的，准予许可并发给医疗机构制剂许可证；对不符合规定条件的，不予许可并书面说明理由。
To prepare preparations, a medical institution shall submit an application to the drug regulatory authority of the provincial people's government where it is located, along with materials proving compliance with the conditions specified in the first paragraph of Article 75 of the Drug Administration Law. The drug regulatory authority of the provincial people's government shall organize a review and make a decision within 30 working days from the date of accepting the application. If the conditions are met, a permit shall be granted and a medical institution preparation license issued; if not, the application shall be rejected with a written explanation.
医疗机构变更医疗机构制剂许可证许可事项的，应当向原发证部门提出申请。原发证部门应当自受理申请之日起15个工作日内进行审查并作出决定。
If a medical institution changes the licensed items of the medical institution preparation license, it shall submit an application to the original issuing authority. The original issuing authority shall conduct a review and make a decision within 15 working days from the date of accepting the application.
医疗机构制剂许可证有效期为5年。有效期届满，需要继续配制制剂的，应当申请重新核发医疗机构制剂许可证。
The validity period of a medical institution preparation license is 5 years. If it is necessary to continue preparing preparations after expiration, an application for reissuance of the medical institution preparation license shall be made.
医疗机构应当向所在地省级人民政府药品监督管理部门报送拟配制制剂的数据、资料和样品，经审评审批取得医疗机构制剂注册证书后，方可配制；但是，仅应用传统工艺配制的中药制剂，医疗机构向所在地省级人民政府药品监督管理部门备案后即可配制。
A medical institution shall submit the data, materials, and samples of the preparations it intends to prepare to the drug regulatory authority of the provincial people's government where it is located, and may prepare them only after obtaining a medical institution preparation registration certificate through review and approval; however, for TCM preparations prepared using only traditional processes, the medical institution may prepare them after filing with the drug regulatory authority of the provincial people's government where it is located.
省级人民政府药品监督管理部门审批医疗机构制剂注册申请时，对制剂的质量标准、配制工艺、标签和说明书一并核准。
When approving a medical institution's preparation registration application, the drug regulatory authority of the provincial people's government shall simultaneously approve the quality standards, preparation processes, labels, and instructions of the preparation.
医疗机构制剂注册证书有效期为3年。有效期届满，需要继续配制的，应当申请再注册。
The validity period of a medical institution preparation registration certificate is 3 years. If it is necessary to continue preparation after expiration, an application for re-registration shall be made.
临床确有需要的儿童用药品，市场上没有供应或者没有供儿童使用的剂型、规格的，由国务院卫生健康主管部门会同国务院药品监督管理部门纳入儿童常用医疗机构制剂清单，支持医疗机构配制、使用，满足儿童患者临床用药需求。
For drugs for children that are clinically truly needed but not available on the market or not available in dosage forms or specifications suitable for children, the competent health department of the State Council, together with the drug regulatory authority of the State Council, shall include them in the list of commonly used medical institution preparations for children, support medical institutions in preparing and using them, and meet the clinical medication needs of pediatric patients.
下列药品不得作为医疗机构制剂：
The following drugs shall not be used as medical institution preparations:
(一)含有尚未用于已注册药品的活性成份的化学药；
(1) Chemical drugs containing active ingredients that have not been used in registered drugs;
(二)已注册药品的活性成份用于新适应症的化学药；
(2) Chemical drugs where the active ingredients of registered drugs are used for new indications;
(三)中药和化学药组成的复方制剂；
(3) Compound preparations composed of TCM and chemical drugs;
(四)中药注射剂；
(4) TCM injections;
(五)医疗用毒性药品；
(5) Toxic drugs for medical use;
(六)除变态反应原以外的生物制品；
(6) Biological products other than allergens;
(七)国务院药品监督管理部门规定的其他药品。
(7) Other drugs specified by the drug regulatory authority of the State Council.
医疗机构配制制剂，应当遵守医疗机构制剂配制质量管理规范，建立健全制剂配制质量管理体系，保证制剂配制全过程持续符合法定要求。医疗机构制剂配制质量管理规范由国务院药品监督管理部门制定。
When preparing preparations, medical institutions shall comply with the Good Preparation Practice for Medical Institution Preparations, establish and improve a preparation quality management system, and ensure that the entire preparation process continuously meets legal requirements. The Good Preparation Practice for Medical Institution Preparations shall be formulated by the drug regulatory authority of the State Council.
医疗机构的法定代表人、主要负责人对本医疗机构的制剂配制活动全面负责。
The legal representative and principal responsible person of a medical institution shall be fully responsible for the preparation activities of the medical institution.
医疗机构制剂只能凭医师处方在本医疗机构使用，不得在市场上销售或者变相销售，不得发布医疗机构制剂广告。
Medical institution preparations may only be used within the medical institution with a physician's prescription, and shall not be sold or marketed in any form, nor shall advertisements for medical institution preparations be published.
发生灾情、疫情以及其他突发事件或者临床急需而市场上没有供应时，经省级人民政府药品监督管理部门批准，在规定期限内，医疗机构制剂可以在指定的医疗机构之间调剂使用；但是，调剂使用国务院药品监督管理部门规定的特殊医疗机构制剂以及跨省级行政区域调剂使用医疗机构制剂的，应当经国务院药品监督管理部门批准。省级以上人民政府药品监督管理部门应当自受理申请之日起5个工作日内进行审查并作出决定。
In the event of disasters, epidemics, or other emergencies, or when clinically urgently needed and not available on the market, with the approval of the drug regulatory authority of the provincial people's government, medical institution preparations may be transferred and used among designated medical institutions within a specified period; however, the transfer and use of special medical institution preparations specified by the drug regulatory authority of the State Council and the cross-provincial transfer and use of medical institution preparations shall be approved by the drug regulatory authority of the State Council. The drug regulatory authority at or above the provincial level shall conduct a review and make a decision within 5 working days from the date of accepting the application.
医疗机构发现疑似药品不良反应，应当按照规定及时报告药品监督管理部门和卫生健康主管部门。
If a medical institution discovers a suspected adverse drug reaction, it shall promptly report it to the drug regulatory authority and the competent health department in accordance with regulations.
医疗机构发现疑似药品不良反应聚集性事件，应当及时对患者进行救治、采取措施控制风险，并按照规定及时报告药品监督管理部门和卫生健康主管部门。药品监督管理部门和卫生健康主管部门接到报告后，应当及时调查处理。
If a medical institution discovers a cluster of suspected adverse drug reactions, it shall promptly treat patients, take measures to control risks, and promptly report to the drug regulatory authority and the competent health department in accordance with regulations. Upon receiving the report, the drug regulatory authority and the competent health department shall promptly investigate and handle the matter.
医疗机构发现购进、使用的药品存在质量问题，应当立即采取措施控制风险，及时告知供货单位和药品上市许可持有人，并向所在地县级人民政府药品监督管理部门报告。
If a medical institution discovers quality problems in the drugs it purchases and uses, it shall immediately take measures to control risks, promptly notify the supplier and the drug marketing authorization holder, and report to the local drug regulatory authority of the county people's government.
药品上市许可持有人、供货单位应当提供或者公布电子邮件地址、电话、传真等，方便医疗机构告知相关信息。
The drug marketing authorization holder and the supplier shall provide or publish email addresses, telephone numbers, fax numbers, etc., to facilitate the medical institution in notifying relevant information.
药品监督管理部门和卫生健康主管部门依据各自职责，分别对药品使用环节的药品质量和药品使用行为进行监督管理。
The drug regulatory authority and the competent health department shall, based on their respective duties, supervise and manage the quality of drugs in the drug use link and the drug use behavior.
监 督 管 理
Supervision and Management
药品监督管理部门实施监督检查，可以采取下列措施：
When conducting supervision and inspection, the drug regulatory authority may take the following measures:
(一)进入药品研制、生产、经营、使用等活动场所以及为药品研制、生产、经营、使用提供相关产品或者服务的场所，实施现场检查、抽取样品；
(1) Enter the premises of drug research, production, distribution, use, and other activities, as well as places that provide related products or services for drug research, production, distribution, and use, to conduct on-site inspections and collect samples;
(二)查阅、复制有关文件、记录、票据、凭证、电子数据等资料，对可能被转移、隐匿或者损毁的资料予以查封、扣押；
(2) Review and copy relevant documents, records, bills, vouchers, electronic data, etc., and seal up or seize materials that may be transferred, concealed, or damaged;
(三)查封、扣押有证据证明可能危害人体健康的药品及其有关原料、辅料、直接接触药品的包装材料和容器；
(3) Seal up or seize drugs that have evidence proving they may endanger human health, as well as their related raw materials, excipients, and packaging materials and containers that come into direct contact with drugs;
(四)查封、扣押有证据证明可能用于违法活动的工具、设施设备、场所。
(4) Seal up or seize tools, facilities, equipment, and premises that have evidence proving they may be used for illegal activities.
药品监督管理部门进行监督检查时，执法人员不得少于两人，并应当出示执法证件。有关单位和个人对监督检查应当予以配合，不得拒绝、阻挠。
When conducting supervision and inspection, the drug regulatory authority shall have at least two law enforcement officers present, who shall show their law enforcement credentials. Relevant units and individuals shall cooperate with the supervision and inspection and shall not refuse or obstruct it.
国务院药品监督管理部门应当制定统一的药品追溯标准和规范。药品上市许可持有人、药品生产企业应当按照规定在药品包装上赋予追溯标识。药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当按照规定提供追溯信息，保证药品可追溯。
The drug regulatory authority of the State Council shall formulate unified drug traceability standards and specifications. Drug marketing authorization holders and drug manufacturers shall affix traceability identifiers on drug packaging in accordance with regulations. Drug marketing authorization holders, drug manufacturers, drug distributors, and medical institutions shall provide traceability information in accordance with regulations to ensure drug traceability.
国务院药品监督管理部门按照程序设置国家药品专业技术机构。省级人民政府药品监督管理部门可以根据当地药品产业发展情况和监督管理工作需要，按照程序设置地方药品专业技术机构。国家药品专业技术机构应当加强对地方药品专业技术机构的技术指导。
The drug regulatory authority of the State Council shall set up national drug professional technical institutions in accordance with procedures. The drug regulatory authority of the provincial people's government may, based on the development of the local pharmaceutical industry and the needs of supervision and management, set up local drug professional technical institutions in accordance with procedures. National drug professional technical institutions shall strengthen technical guidance to local drug professional technical institutions.
省级以上人民政府药品监督管理部门根据药品监督管理工作需要，可以指定符合条件的机构承担相关专业技术工作。
The drug regulatory authority at or above the provincial level may, based on the needs of drug supervision and management, designate qualified institutions to undertake relevant professional technical work.
药品质量抽查检验应当遵循科学、规范、公正原则。
Drug quality sampling and testing shall follow the principles of science, standardization, and fairness.
药品监督管理部门应当根据药品监督管理工作需要，制定并实施药品质量抽查检验计划。
The drug regulatory authority shall, based on the needs of drug supervision and management, formulate and implement plans for drug quality sampling and testing.
药品质量抽查检验中，药品抽样应当由两名以上抽样人员按照国务院药品监督管理部门的规定实施。被抽样单位应当配合抽样人员进行抽样。被抽样单位没有正当理由不予配合的，药品监督管理部门可以责令被抽样单位暂停销售、使用被抽样药品。
In drug quality sampling and testing, drug sampling shall be carried out by at least two sampling personnel in accordance with the provisions of the drug regulatory authority of the State Council. The sampled unit shall cooperate with the sampling personnel in sampling. If the sampled unit fails to cooperate withoutlegitimate reason, the drug regulatory authority may order the sampled unit to suspend the sale and use of the sampled drugs.
根据药品监督管理工作需要，药品监督管理部门可以对辅料、直接接触药品的包装材料和容器质量进行抽查检验。
Based on the needs of drug supervision and management, the drug regulatory authority may conduct sampling and testing of the quality of excipients and packaging materials and containers that come into direct contact with drugs.
当事人对药品检验机构的检验结果有异议的，可以自收到药品检验结果之日起7日内申请复验。
If a party disagrees with the test results of a drug testing institution, it may apply for a re-test within 7 days from the date of receiving the drug test results.
申请复验的，应当按照规定向复验机构预先支付复验检验费用。复验检验结论与原检验结论不一致的，复验检验费用由原药品检验机构承担。
When applying for a re-test, the re-test fee shall be paid in advance to the re-test institution in accordance with regulations. If the re-test conclusion is inconsistent with the original test conclusion, the re-test fee shall be borne by the original drug testing institution.
国家药品标准规定不予复验的检验项目，或者有国务院药品监督管理部门规定的其他不予复验的情形的，不予复验。
If the national drug standards specify that a test item is not subject to re-test, or if there are other circumstances specified by the drug regulatory authority of the State Council that preclude re-test, re-test shall not be conducted.
省级以上人民政府药品监督管理部门公告的药品质量抽查检验结果应当包括被抽检药品的品名、样品来源、标示的药品上市许可持有人和生产企业或者标示的医疗机构、产品批号、规格、检验机构、检验依据、检验结论、不符合规定项目等内容。药品质量抽查检验结果公告不当的，发布部门应当自确认不当之日起5个工作日内，在原公告范围内予以更正。
The results of drug quality sampling and testing announced by the drug regulatory authority at or above the provincial level shall include the name of the sampled drug, sample source, the indicated drug marketing authorization holder and manufacturer or the indicated medical institution, batch number, specification, testing institution, testing basis, test conclusion, non-conforming items, etc. If the announcement of drug quality sampling and testing results is improper, the issuing department shall correct it within 5 working days from the date of confirming the impropriety, within the original scope of the announcement.
对可能掺杂、掺假的药品，按照国家药品标准、药品注册标准规定的检验项目和检验方法无法检验的，药品检验机构可以使用国务院药品监督管理部门批准的补充检验项目和检验方法进行检验。使用补充检验项目和检验方法得出的检验结果，可以作为认定药品质量的依据。
For drugs that may be adulterated oradulterate, if the test items and methods specified in the national drug standards or drug registration standards cannot be used for testing, the drug testing institution may use supplementary test items and methods approved by the drug regulatory authority of the State Council for testing. The test results obtained using supplementary test items and methods may be used as the basis for determining drug quality.
药品监督管理部门依照药品管理法第九十九条第三款规定采取暂停生产、销售、使用、进口等风险控制措施的，药品上市许可持有人、药品生产企业、药品经营企业、医疗机构应当进行整改，消除安全隐患。药品监督管理部门评估认为符合相关要求的，应当解除已采取的风险控制措施。
If the drug regulatory authority takes risk control measures such as suspending production, sale, use, or import in accordance with the third paragraph of Article 99 of the Drug Administration Law, the drug marketing authorization holder, drug manufacturer, drug distributor, and medical institution shall make corrections to eliminate safety hazards. If the drug regulatory authority assesses that the relevant requirements are met, it shall lift the risk control measures that have been taken.
在省级以上人民政府药品监督管理部门采取前款规定的风险控制措施期间，不得发布相关药品的广告；已经发布的，应当立即停止。
During the period when the drug regulatory authority at or above the provincial level takes the risk control measures specified in the preceding paragraph, advertisements for the relevant drugs shall not be published; if already published, they shall be immediately stopped.
下列情形属于药品管理法第九十八条第二款第二项规定的假药：
The following circumstances constitute counterfeit drugs as specified in Item (2) of the second paragraph of Article 98 of the Drug Administration Law:
(一)不具备疾病预防、治疗、诊断功能的物质或者成份不明的物质，在标签、说明书上宣称具有疾病预防、治疗、诊断功能冒充药品的；
(1) Substances that do not have the functions of disease prevention, treatment, or diagnosis, or substances with unknown ingredients, are labeled or instructed as having disease prevention, treatment, or diagnostic functions to impersonate drugs;
(二)使用其他药品的名称或者批准文号，在标签、说明书上标注不具有的适应症或者功能主治的；
(2) Using the name or approval number of another drug, and labeling indications or functionalchief indication that are not possessed on the label or instructions;
(三)药品成份与其在标签、说明书上标注的成份不符的；
(3) The drug ingredients do not match those stated on the label or instructions;
(四)标注虚假的药品批准文号、药品上市许可持有人的；
(4) Labeling a false drug approval number or drug marketing authorization holder;
(五)其他以非药品冒充药品或者以他种药品冒充此种药品的情形。
(5) Other circumstances where a non-drug is impersonated as a drug or one drug is impersonated as another drug.
依照药品管理法第九十八条第二款第四项规定认定假药，以及依照药品管理法第九十八条第三款第三项至第五项规定认定劣药，不需要进行药品检验。依照药品管理法第九十八条第二款、第三款的其他规定认定假药或者劣药，应当进行药品检验；但是，原料、辅料的采购和使用记录等证据能够充分证明属于假药或者劣药的，可以不进行药品检验。
Determining counterfeit drugs in accordance with Item (4) of the second paragraph of Article 98 of the Drug Administration Law, and determining substandard drugs in accordance with Items (3) to (5) of the third paragraph of Article 98 of the Drug Administration Law, does not require drug testing. Determining counterfeit drugs or substandard drugs in accordance with other provisions of the second and third paragraphs of Article 98 of the Drug Administration Law shall require drug testing; however, if evidence such as procurement and use records of raw materials and excipients is sufficient to prove that they are counterfeit or substandard drugs, drug testing may not be required.
发生药品安全事件的单位应当立即采取措施防止危害扩大，并立即报告事件发生地县级人民政府药品监督管理部门。
The unit where a drug safety incident occurs shall immediately take measures to prevent the expansion of harm and immediately report to the drug regulatory authority of the county people's government where the incident occurred.
医疗机构发现发生药品安全事件，应当立即报告事件发生地县级人民政府药品监督管理部门和卫生健康主管部门。
If a medical institution discovers a drug safety incident, it shall immediately report to the drug regulatory authority and the competent health department of the county people's government where the incident occurred.
药品监督管理部门接到报告后，应当按照规定立即报告本级人民政府、上级人民政府药品监督管理部门。
Upon receiving the report, the drug regulatory authority shall immediately report to the people's government at the same level and the drug regulatory authority of the higher-level people's government in accordance with regulations.
县级以上人民政府应当按照药品安全事件应急预案，组织开展应对工作。
The people's government at or above the county level shall organize response work in accordance with the drug safety incident emergency plan.
国家加强药品储备，实行中央和地方两级储备。具体办法由国务院工业和信息化主管部门会同国务院有关部门制定。
The State strengthens drug stockpiling, implementing a two-level stockpiling system at the central and local levels. Specific measures shall be formulated by the competent department of industry and information technology of the State Council together with relevant departments of the State Council.
国务院卫生健康主管部门会同国务院有关部门制定国家药物政策和国家基本药物制度，完善国家基本药物目录管理机制。
The competent health department of the State Council, together with relevant departments of the State Council, shall formulate national drug policies and the national essential drug system, and improve the management mechanism of the national essential drug list.
市场监督管理部门加强药品生产、经营中的反垄断和反不正当竞争监督管理，依法查处垄断、不正当竞争违法行为，维护公平竞争秩序。
Market regulatory authorities shall strengthen supervision and management of anti-monopoly and anti-unfair competition in drug production and distribution, investigate and deal with illegal monopoly and unfair competition acts in accordance with the law, and maintain fair competition order.
药品监督管理等部门在监督管理中发现公职人员涉嫌职务违法或者职务犯罪的问题线索，应当及时移送监察机关。
If drug regulatory authorities and other departments discover clues of public officials suspected of duty-related violations or duty crimes during supervision and management, they shall promptly transfer them to the supervisory authorities.
进行药品注册、实施药品注册检验和强制性检验，可以收取费用。具体收费项目、收费标准分别由国务院财政部门、国务院发展改革部门按照国家有关规定制定。
Fees may be charged for drug registration, drug registration testing, and mandatory testing. The specific charging items and standards shall be formulated by the financial department of the State Council and the development and reform department of the State Council in accordance with state regulations.
法 律 责 任
Legal Liability
有下列情形之一的，由县级以上地方人民政府药品监督管理部门责令限期改正，没收违法生产、销售的药品和违法所得，并处违法生产、销售的药品货值金额10倍以上20倍以下的罚款，违法生产、批发的药品货值金额不足10万元的，按10万元计算，违法零售的药品货值金额不足1万元的，按1万元计算；情节严重的，还应当责令停产停业整顿直至由原发证部门吊销药品生产许可证、药品经营许可证：
Under any of the following circumstances, the drug regulatory authority of the local people's government at or above the county level shall order correction within a specified period, confiscate the illegally produced or sold drugs and illegal gains, and impose a fine of not less than 10 times but not more than 20 times the value of the illegally produced or sold drugs; if the value of the illegally produced or wholesale drugs is less than 100,000 yuan, it shall be calculated as 100,000 yuan; if the value of the illegally retailed drugs is less than 10,000 yuan, it shall be calculated as 10,000 yuan; if the circumstances are serious, it shall also order suspension of production or business for rectification until the original issuing authority revokes the Drug Manufacturing License or Drug Distribution License:
(一)药品上市许可持有人违反本条例第三十六条规定销售取得药品批准证明文件前生产的商业规模批次产品；
(1) The drug marketing authorization holder violates Article 36 of these Regulations by selling commercial-scale batches of products produced before obtaining the drug approval certificate;
(二)中药饮片生产企业委托炮制中药饮片或者中药配方颗粒生产企业委托生产中药配方颗粒；
(2) A Chinese medicine decoction pieces manufacturer entrusts the processing of Chinese medicine decoction pieces, or a Chinese medicine formula granule manufacturer entrusts the production of Chinese medicine formula granules;
(三)药品经营企业经营中药配方颗粒、医疗机构制剂；
(3) A drug distribution enterprise operates Chinese medicine formula granules or medical institution preparations;
(四)违反本条例第四十六条规定通过网络销售药品。
(4) Selling drugs through the internet in violation of Article 46 of these Regulations.
有下列情形之一的，由省级人民政府药品监督管理部门责令限期改正，给予警告；逾期不改正的，处10万元以上50万元以下的罚款：
Under any of the following circumstances, the drug regulatory authority of the provincial people's government shall order correction within a specified period and give a warning; if correction is not made within the time limit, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed:
(一)中药饮片生产企业、中药配方颗粒生产企业跨省级行政区域销售中药饮片、中药配方颗粒未依照本条例第三十九条第三款、第四十条第四款规定备案；
(1) A Chinese medicine decoction pieces manufacturer or Chinese medicine formula granule manufacturer sells Chinese medicine decoction pieces or Chinese medicine formula granules across provincial administrative regions without filing in accordance with Article 39, paragraph 3, or Article 40, paragraph 4 of these Regulations;
(二)中药配方颗粒生产企业生产中药配方颗粒未依照本条例第四十条第一款规定备案。
(2) A Chinese medicine formula granule manufacturer produces Chinese medicine formula granules without filing in accordance with Article 40, paragraph 1 of these Regulations.
医疗机构未经批准使用其他医疗机构配制的制剂的，依照药品管理法第一百二十九条、第一百三十九条规定予以处罚。
If a medical institution uses preparations prepared by other medical institutions without approval, it shall be punished in accordance with Articles 129 and 139 of the Drug Administration Law.
医疗机构有下列情形之一的，由县级以上地方人民政府药品监督管理部门责令限期改正；逾期不改正的，处1万元以上10万元以下的罚款：
If a medical institution has any of the following circumstances, the drug regulatory authority of the local people's government at or above the county level shall order correction within a specified period; if correction is not made within the time limit, a fine of not less than 10,000 yuan but not more than 100,000 yuan shall be imposed:
(一)未按照规定制定并实施药品进货检查验收、保管、使用等管理制度；
(1) Failing to formulate and implement management systems for drug purchase inspection and acceptance, storage, and use as required;
(二)发现购进、使用的药品存在质量问题，未按照规定采取措施或者报告。
(2) Discovering quality problems in purchased or used drugs without taking measures or reporting as required.
申请药物非临床安全性评价研究机构资格、药物临床试验许可、药品生产许可、药品经营许可、医疗机构制剂许可、药品注册等许可，提供虚假证明、数据、资料、样品或者采取其他欺骗手段的，县级以上人民政府药品监督管理部门不予受理或者不予许可，10年内不受理其相应申请，并处50万元以上500万元以下的罚款；情节严重的，还应当对法定代表人、主要负责人、直接负责的主管人员和其他责任人员处2万元以上20万元以下的罚款，禁止其10年内从事药品生产经营活动。
If an applicant provides false certificates, data, materials, samples, or uses other deceptive means when applying for qualifications for drug non-clinical safety evaluation research institutions, drug clinical trial permits, drug manufacturing permits, drug distribution permits, medical institution preparation permits, drug registration, or other permits, the drug regulatory authority of the people's government at or above the county level shall not accept or grant the permit, and shall not accept the corresponding application for 10 years, and shall impose a fine of not less than 500,000 yuan but not more than 5,000,000 yuan; if the circumstances are serious, it shall also impose a fine of not less than 20,000 yuan but not more than 200,000 yuan on the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons, and prohibit them from engaging in drug production and distribution activities for 10 years.
申请人提交的虚假证明、数据、资料、样品是药物非临床安全性评价研究机构、药物临床试验机构或者其他接受委托开展药品研制相关活动的机构伪造或者编造的，由省级以上人民政府药品监督管理部门依照药品管理法第一百二十六条规定对药物非临床安全性评价研究机构、药物临床试验机构或者其他接受委托开展药品研制相关活动的机构予以处罚。
If the false certificates, data, materials, or samples submitted by the applicant are forged or fabricated by a drug non-clinical safety evaluation research institution, drug clinical trial institution, or other institution entrusted to carry out drug research-related activities, the drug regulatory authority at or above the provincial level shall punish the drug non-clinical safety evaluation research institution, drug clinical trial institution, or other institution entrusted to carry out drug research-related activities in accordance with Article 126 of the Drug Administration Law.
已办理备案的药物临床试验机构不符合备案条件的，由省级以上人民政府药品监督管理部门责令限期改正；逾期仍不符合备案条件的，取消相关药物临床试验专业备案或者药物临床试验机构备案，禁止其1年内开展相关专业药物临床试验或者禁止其1年内开展药物临床试验。
If a drug clinical trial institution that has completed filing does not meet the filing conditions, the drug regulatory authority at or above the provincial level shall order correction within a specified period; if it still does not meet the filing conditions after the time limit, the filing of the relevant drug clinical trial specialty or the drug clinical trial institution shall be cancelled, and it shall be prohibited from conducting drug clinical trials in the relevant specialty for 1 year or from conducting drug clinical trials for 1 year.
办理药物临床试验机构备案时提供虚假证明的，由省级以上人民政府药品监督管理部门取消相关药物临床试验专业备案或者药物临床试验机构备案，禁止其3年内开展相关专业药物临床试验或者禁止其3年内开展药物临床试验，没收违法所得，并处10万元以上50万元以下的罚款，相关临床试验数据不得用于申请药品注册。
If false certificates are provided when filing a drug clinical trial institution, the drug regulatory authority at or above the provincial level shall cancel the filing of the relevant drug clinical trial specialty or the drug clinical trial institution, prohibit it from conducting drug clinical trials in the relevant specialty for 3 years or from conducting drug clinical trials for 3 years, confiscate illegal gains, and impose a fine of not less than 100,000 yuan but not more than 500,000 yuan; the relevant clinical trial data shall not be used for drug registration applications.
药品网络交易第三方平台提供者未按照规定建立健全药品网络销售质量管理体系的，由省级人民政府药品监督管理部门责令限期改正，给予警告；逾期不改正的，处10万元以上50万元以下的罚款；情节严重的，处50万元以上200万元以下的罚款。
If a third-party platform provider for drug internet transactions fails to establish and improve a drug online sales quality management system as required, the drug regulatory authority of the provincial people's government shall order correction within a specified period and give a warning; if correction is not made within the time limit, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed; if the circumstances are serious, a fine of not less than 500,000 yuan but not more than 2,000,000 yuan shall be imposed.
药品网络交易第三方平台提供者、药品上市许可持有人、药品经营企业为其他药品网络交易第三方平台提供者、药品上市许可持有人、药品经营企业通过网络销售药品提供信息展示、链接跳转等服务，违反国务院药品监督管理部门规定的，由省级人民政府药品监督管理部门责令限期改正，给予警告；逾期不改正的，没收违法所得，并处10万元以上50万元以下的罚款；情节严重的，没收违法所得，并处50万元以上200万元以下的罚款。
If a third-party platform provider for drug internet transactions, drug marketing authorization holder, or drug distribution enterprise provides information display, link jump, or other services for other third-party platform providers for drug internet transactions, drug marketing authorization holders, or drug distribution enterprises to sell drugs through the internet, in violation of the provisions of the drug regulatory authority of the State Council, the drug regulatory authority of the provincial people's government shall order correction within a specified period and give a warning; if correction is not made within the time limit, illegal gains shall be confiscated, and a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed; if the circumstances are serious, illegal gains shall be confiscated, and a fine of not less than 500,000 yuan but not more than 2,000,000 yuan shall be imposed.
拒不执行药品监督管理部门依法采取的暂停生产、销售、使用、进口等风险控制措施的，由县级以上人民政府药品监督管理部门处违法生产、销售、使用、进口药品货值金额5倍以上10倍以下的罚款，货值金额不足1万元的，按1万元计算；情节严重的，还应当责令停产停业整顿直至由原发证部门吊销药品批准证明文件、药品生产许可证、药品经营许可证、医疗机构制剂许可证，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员处2万元以上20万元以下的罚款。
If a party refuses to implement risk control measures such as suspension of production, sale, use, or import lawfully taken by the drug regulatory authority, the drug regulatory authority of the people's government at or above the county level shall impose a fine of not less than 5 times but not more than 10 times the value of the illegally produced, sold, used, or imported drugs; if the value is less than 10,000 yuan, it shall be calculated as 10,000 yuan; if the circumstances are serious, it shall also order suspension of production or business for rectification until the original issuing authority revokes the drug approval certificate, Drug Manufacturing License, Drug Distribution License, or Medical Institution Preparation License, and impose a fine of not less than 20,000 yuan but not more than 200,000 yuan on the legal representative, principal responsible person, directly responsible supervisor, and other responsible persons.
违反药品管理法、疫苗管理法、本条例规定，拒绝、阻挠监督检查的，由县级以上人民政府药品监督管理部门责令限期改正，处5万元以下的罚款；情节严重的，责令停产停业整顿。
If a party violates the Drug Administration Law, Vaccine Administration Law, or these Regulations by refusing or obstructing supervision and inspection, the drug regulatory authority of the people's government at or above the county level shall order correction within a specified period and impose a fine of not more than 50,000 yuan; if the circumstances are serious, it shall order suspension of production or business for rectification.
药品经营企业、医疗机构履行了药品管理法、疫苗管理法、本条例规定的进货检查验收等义务，有充分证据证明其不知道所销售或者使用的药品是假药、劣药的，免予处罚，但应当收缴其销售或者使用的假药、劣药；造成人身、财产或者其他损害的，依法承担赔偿责任。
If a drug distribution enterprise or medical institution has fulfilled the obligations of purchase inspection and acceptance as required by the Drug Administration Law, Vaccine Administration Law, and these Regulations, and has sufficient evidence to prove that it did not know that the drugs sold or used were counterfeit or substandard, it shall be exempted from punishment, but the counterfeit or substandard drugs sold or used shall be confiscated; if personal injury, property damage, or other harm is caused, it shall bear compensation liability in accordance with the law.
药品监督管理部门及其工作人员违反本条例规定，泄露药品上市许可持有人未披露的试验数据或者其他数据，造成药品上市许可持有人损失的，由药品监督管理部门依法承担赔偿责任；药品监督管理部门赔偿损失后，应当责令故意或者有重大过失的工作人员承担部分或者全部赔偿费用，并对负有责任的领导人员和直接责任人员依法给予处分。
If a drug regulatory authority or its staff member violates these Regulations by disclosing undisclosed test data or other data of a drug marketing authorization holder, causing losses to the drug marketing authorization holder, the drug regulatory authority shall bear compensation liability in accordance with the law; after the drug regulatory authority compensates for the losses, it shall order the staff member who acted intentionally or with gross negligence to bear part or all of the compensation costs, and shall impose sanctions on the responsible leaders and directly responsible personnel in accordance with the law.
附 则
Supplementary Provisions
药品注册审评所需时间以及药物非临床安全性评价研究机构资格申请、药品生产许可申请、药品经营许可申请、医疗机构制剂许可申请审查中涉及的技术审核所需时间不计入药品监督管理部门实施行政许可的期限。
The time required for drug registration review and the time required for technical review involved in the examination of applications for drug non-clinical safety evaluation research institution qualifications, drug manufacturing permits, drug distribution permits, and medical institution preparation permits shall not be counted within the time limit for the drug regulatory authority to implement administrative licensing.
本条例自2026年5月15日起施行。
These Regulations shall come into force on May 15, 2026.