KYB CHINA(1989年1月13日中华人民共和国国务院令第25号发布 根据2011年1月8日《国务院关于废止和修改部分行政法规的决定》第一次修订 根据2017年3月1日《国务院关于修改和废止部分行政法规的决定》第二次修订 根据2022年3月29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 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》第四次修订)
(Promulgated by Decree No. 25 of the State Council of the People's Republic of China on January 13, 1989; first revision in accordance with the Decision of the State Council on Repealing and Amending Certain Administrative Regulations on January 8, 2011; second revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on March 1, 2017; third revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on March 29, 2022; fourth revision in accordance with the Decision of the State Council on Amending and Repealing Certain Administrative Regulations on December 6, 2024)
总 则
General Provisions
为了加强放射性药品的管理，根据《中华人民共和国药品管理法》(以下称《药品管理法》)的规定，制定本办法。
These Measures are formulated in accordance with the provisions of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) to strengthen the administration of radiopharmaceuticals.
放射性药品是指用于临床诊断或者治疗的放射性核素制剂或者其标记药物。
Radiopharmaceuticals refer to radionuclide preparations or their labeled drugs used for clinical diagnosis or treatment.
凡在中华人民共和国领域内进行放射性药品的研究、生产、经营、运输、使用、检验、监督管理的单位和个人都必须遵守本办法。
All units and individuals engaged in the research, production, operation, transport, use, inspection, and supervision of radiopharmaceuticals within the territory of the People's Republic of China must comply with these Measures.
国务院药品监督管理部门负责全国放射性药品监督管理工作。国务院国防科技工业主管部门依据职责负责与放射性药品有关的管理工作。国务院环境保护主管部门负责与放射性药品有关的辐射安全与防护的监督管理工作。
The drug regulatory department of the State Council is responsible for the supervision and administration of radiopharmaceuticals nationwide. The competent department of defense science, technology and industry of the State Council is responsible for the administration related to radiopharmaceuticals according to its functions. The competent department of environmental protection of the State Council is responsible for the supervision and administration of radiation safety and protection related to radiopharmaceuticals.
放射性新药的研制、临床研究和审批
Research, Clinical Study and Approval of New Radiopharmaceuticals
放射性新药的研制内容，包括工艺路线、质量标准、临床前药理及临床研究。研制单位在制订新药工艺路线的同时，必须研究该药的理化性能、纯度(包括核素纯度)及检验方法、药理、毒理、动物药代动力学、放射性比活度、剂量、剂型、稳定性等。
The research content of new radiopharmaceuticals includes process routes, quality standards, preclinical pharmacology and clinical studies. While formulating the process route of a new drug, the research unit must study the physicochemical properties, purity (including radionuclide purity) and testing methods, pharmacology, toxicology, animal pharmacokinetics, specific radioactivity, dosage, dosage form, stability, etc.
研制单位对放射免疫分析药盒必须进行可测限度、范围、特异性、准确度、精密度、稳定性等方法学的研究。
For radioimmunoassay kits, the research unit must conduct methodological studies on detectable limits, range, specificity, accuracy, precision, stability, etc.
放射性新药的分类，按国务院药品监督管理部门有关药品注册的规定办理。
The classification of new radiopharmaceuticals shall be handled in accordance with the relevant provisions of the drug regulatory department of the State Council on drug registration.
研制单位研制的放射性新药，在进行临床试验或者验证前，应当向国务院药品监督管理部门提出申请，按规定报送资料及样品，经国务院药品监督管理部门审批同意后，在国务院药品监督管理部门指定的药物临床试验机构进行临床研究。
Before conducting clinical trials or verification of a new radiopharmaceutical developed by a research unit, the research unit shall submit an application to the drug regulatory department of the State Council, along with the required materials and samples. After approval by the drug regulatory department of the State Council, clinical studies shall be conducted in drug clinical trial institutions designated by the drug regulatory department of the State Council.
研制单位在放射性新药临床研究结束后，向国务院药品监督管理部门提出申请，经国务院药品监督管理部门审核批准，发给新药证书。国务院药品监督管理部门在审核批准时，应当征求国务院国防科技工业主管部门的意见。
After the completion of clinical studies of a new radiopharmaceutical, the research unit shall submit an application to the drug regulatory department of the State Council. Upon review and approval by the drug regulatory department of the State Council, a new drug certificate shall be issued. When reviewing and approving, the drug regulatory department of the State Council shall seek the opinions of the competent department of defense science, technology and industry of the State Council.
放射性新药投入生产，需由生产单位或者取得放射性药品生产许可证的研制单位，凭新药证书(副本)向国务院药品监督管理部门提出生产该药的申请，并提供样品，由国务院药品监督管理部门审核发给批准文号。
To put a new radiopharmaceutical into production, the production unit or the research unit that has obtained a radiopharmaceutical production license shall submit an application to the drug regulatory department of the State Council for the production of the drug, together with the new drug certificate (copy) and provide samples. The drug regulatory department of the State Council shall, upon review, issue an approval number.
放射性药品的生产、经营和进出口
Production, Operation, Import and Export of Radiopharmaceuticals
国家根据需要，对放射性药品的生产企业实行合理布局。
The State shall implement a rational layout for production enterprises of radiopharmaceuticals according to needs.
开办放射性药品生产、经营企业，必须具备《药品管理法》规定的条件，符合国家有关放射性同位素安全和防护的规定与标准，并履行环境影响评价文件的审批手续；开办放射性药品生产企业，经所在省、自治区、直辖市国防科技工业主管部门审查同意，所在省、自治区、直辖市药品监督管理部门审核批准后，由所在省、自治区、直辖市药品监督管理部门发给《放射性药品生产企业许可证》；开办放射性药品经营企业，经所在省、自治区、直辖市药品监督管理部门审核并征求所在省、自治区、直辖市国防科技工业主管部门意见后批准的，由所在省、自治区、直辖市药品监督管理部门发给《放射性药品经营企业许可证》。无许可证的生产、经营企业，一律不准生产、销售放射性药品。
To establish a radiopharmaceutical production or operation enterprise, the conditions stipulated in the Drug Administration Law must be met, the relevant national regulations and standards on the safety and protection of radioactive isotopes must be complied with, and the approval procedures for environmental impact assessment documents must be fulfilled. To establish a radiopharmaceutical production enterprise, after review and consent by the competent department of defense science, technology and industry of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located, and after review and approval by the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall issue the Radiopharmaceutical Production Enterprise License. To establish a radiopharmaceutical operation enterprise, after review by the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government and after seeking the opinions of the competent department of defense science, technology and industry of the province, autonomous region, or municipality directly under the Central Government, and upon approval, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall issue the Radiopharmaceutical Operation Enterprise License. No production or operation enterprise without a license shall be allowed to produce or sell radiopharmaceuticals.
《放射性药品生产企业许可证》、《放射性药品经营企业许可证》的有效期为5年，期满前6个月，放射性药品生产、经营企业应当分别向原发证的药品监督管理部门重新提出申请，按第十条审批程序批准后，换发新证。
The Radiopharmaceutical Production Enterprise License and the Radiopharmaceutical Operation Enterprise License are valid for five years. Six months before the expiration, the radiopharmaceutical production or operation enterprise shall re-apply to the original issuing drug regulatory department. After approval in accordance with the approval procedures in Article 10, a new license shall be issued.
放射性药品生产企业生产已有国家标准的放射性药品，必须经国务院药品监督管理部门征求国务院国防科技工业主管部门意见后审核批准，并发给批准文号。凡是改变国务院药品监督管理部门已批准的生产工艺路线和药品标准的，生产单位必须按原报批程序提出补充申请，经国务院药品监督管理部门批准后方能生产。
To produce a radiopharmaceutical that already has a national standard, a radiopharmaceutical production enterprise must obtain approval from the drug regulatory department of the State Council after seeking the opinions of the competent department of defense science, technology and industry of the State Council, and an approval number shall be issued. If the production process route or drug standard already approved by the drug regulatory department of the State Council is changed, the production unit must submit a supplementary application in accordance with the original approval procedures, and production may only proceed after approval by the drug regulatory department of the State Council.
放射性药品生产、经营企业，必须配备与生产、经营放射性药品相适应的专业技术人员，具有安全、防护和废气、废物、废水处理等设施，并建立严格的质量管理制度。
Radiopharmaceutical production and operation enterprises must be equipped with professional and technical personnel suitable for the production and operation of radiopharmaceuticals, have facilities for safety, protection, and treatment of exhaust gas, waste water, and solid waste, and establish a strict quality management system.
放射性药品生产、经营企业，必须建立质量检验机构，严格实行生产全过程的质量控制和检验。产品出厂前，须经质量检验。符合国家药品标准的产品方可出厂，不符合标准的产品一律不准出厂。
Radiopharmaceutical production and operation enterprises must establish a quality inspection institution and strictly implement quality control and inspection throughout the entire production process. Before leaving the factory, products must undergo quality inspection. Only products that meet national drug standards may leave the factory; products that do not meet the standards shall not leave the factory.
经国务院药品监督管理部门审核批准的含有短半衰期放射性核素的药品，可以边检验边出厂，但发现质量不符合国家药品标准时，该药品的生产企业应当立即停止生产、销售，并立即通知使用单位停止使用，同时报告国务院药品监督管理、卫生行政、国防科技工业主管部门。
For drugs containing short half-life radionuclides that have been reviewed and approved by the drug regulatory department of the State Council, they may be released while being inspected. However, if the quality is found not to meet the national drug standards, the production enterprise of such drugs shall immediately stop production and sales, and immediately notify the user units to stop use, and simultaneously report to the drug regulatory department, the health administrative department, and the competent department of defense science, technology and industry of the State Council.
进口的放射性药品品种，必须符合我国的药品标准或者其他药用要求，并依照《药品管理法》的规定取得进口药品注册证书。
Imported varieties of radiopharmaceuticals must meet the drug standards of China or other medicinal requirements, and an import drug registration certificate must be obtained in accordance with the provisions of the Drug Administration Law.
进出口放射性药品，应当按照国家有关对外贸易、放射性同位素安全和防护的规定，办理进出口手续。
The import and export of radiopharmaceuticals shall go through the import and export procedures in accordance with the relevant national provisions on foreign trade and the safety and protection of radioactive isotopes.
进口放射性药品，必须经国务院药品监督管理部门指定的药品检验机构抽样检验；检验合格的，方准进口。
Imported radiopharmaceuticals must be sampled and inspected by a drug inspection institution designated by the drug regulatory department of the State Council; only those that pass the inspection may be imported.
对于经国务院药品监督管理部门审核批准的含有短半衰期放射性核素的药品，在保证安全使用的情况下，可以采取边进口检验，边投入使用的办法。进口检验单位发现药品质量不符合要求时，应当立即通知使用单位停止使用，并报告国务院药品监督管理、卫生行政、国防科技工业主管部门。
For drugs containing short half-life radionuclides that have been reviewed and approved by the drug regulatory department of the State Council, under the condition of ensuring safe use, the method of importing while inspecting and putting into use may be adopted. If the import inspection unit finds that the drug quality does not meet the requirements, it shall immediately notify the user unit to stop use and report to the drug regulatory department, the health administrative department, and the competent department of defense science, technology and industry of the State Council.
放射性药品的包装和运输
Packaging and Transport of Radiopharmaceuticals
放射性药品的包装必须安全实用，符合放射性药品质量要求，具有与放射性剂量相适应的防护装置。包装必须分内包装和外包装两部分，外包装必须贴有商标、标签、说明书和放射性药品标志，内包装必须贴有标签。
The packaging of radiopharmaceuticals must be safe and practical, meet the quality requirements of radiopharmaceuticals, and have protective devices commensurate with the radioactive dose. The packaging must be divided into inner packaging and outer packaging. The outer packaging must be affixed with a trademark, label, instructions, and a radiopharmaceutical symbol; the inner packaging must be affixed with a label.
标签必须注明药品品名、放射性比活度、装量。
The label must indicate the drug name, specific radioactivity, and quantity.
说明书除注明前款内容外，还须注明生产单位、批准文号、批号、主要成份、出厂日期、放射性核素半衰期、适应症、用法、用量、禁忌症、有效期和注意事项等。
In addition to the contents mentioned in the preceding paragraph, the instructions must also indicate the production unit, approval number, batch number, main ingredients, date of manufacture, half-life of the radionuclide, indications, usage, dosage, contraindications, expiry date, and precautions.
放射性药品的运输，按国家运输、邮政等部门制订的有关规定执行。
The transport of radiopharmaceuticals shall be carried out in accordance with the relevant regulations formulated by the national transport, postal and other departments.
严禁任何单位和个人随身携带放射性药品乘坐公共交通运输工具。
It is strictly prohibited for any unit or individual to carry radiopharmaceuticals on public transport vehicles.
放射性药品的使用
Use of Radiopharmaceuticals
医疗单位设置核医学科、室(同位素室)，必须配备与其医疗任务相适应的并经核医学技术培训的技术人员。非核医学专业技术人员未经培训，不得从事放射性药品使用工作。
Medical units that set up nuclear medicine departments or rooms (isotope rooms) must be equipped with technical personnel who are suitable for their medical tasks and have received training in nuclear medicine technology. Non-nuclear medicine professional technical personnel who have not received training shall not engage in the use of radiopharmaceuticals.
医疗单位使用放射性药品应当符合国家有关放射性同位素安全和防护的规定，具有与所使用放射性药品相适应的场所、设备、卫生环境和专用的仓储设施。
Medical units using radiopharmaceuticals shall comply with the relevant national provisions on the safety and protection of radioactive isotopes, and have premises, equipment, sanitary environment, and dedicated storage facilities suitable for the radiopharmaceuticals used.
医疗单位配制放射性制剂，应当符合《药品管理法》及其实施条例的相关规定。
The preparation of radiopharmaceutical preparations by medical units shall comply with the relevant provisions of the Drug Administration Law and its implementing regulations.
医疗单位使用配制的放射性制剂，应当向所在地省、自治区、直辖市药品监督管理部门申请核发相应等级的《放射性药品使用许可证》。
Medical units using self-prepared radiopharmaceutical preparations shall apply to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where they are located for the issuance of a Radiopharmaceutical Use Permit of the corresponding level.
《放射性药品使用许可证》有效期为5年，期满前6个月，医疗单位应当向原发证的行政部门重新提出申请，经审核批准后，换发新证。
The Radiopharmaceutical Use Permit is valid for five years. Six months before the expiration, the medical unit shall re-apply to the original issuing administrative department, and after review and approval, a new permit shall be issued.
医疗单位负责对使用的放射性药品进行临床质量检验、收集药品不良反应等项工作，并定期向所在地药品监督管理、卫生行政部门报告。由省、自治区、直辖市药品监督管理、卫生行政部门汇总后分别报国务院药品监督管理、卫生行政部门。
Medical units are responsible for clinical quality inspection of the radiopharmaceuticals they use, collection of adverse drug reactions, and other work, and shall regularly report to the local drug regulatory department and health administrative department. The drug regulatory department and health administrative department of the province, autonomous region, or municipality directly under the Central Government shall summarize and report to the drug regulatory department and health administrative department of the State Council respectively.
放射性药品使用后的废物(包括患者排出物)，必须按国家有关规定妥善处置。
Waste (including patient excreta) after the use of radiopharmaceuticals must be properly disposed of in accordance with the relevant national provisions.
放射性药品标准和检验
Standards and Inspection of Radiopharmaceuticals
放射性药品的国家标准，由国务院药品监督管理部门药典委员会负责制定和修订，报国务院药品监督管理部门审批颁发。
The national standards for radiopharmaceuticals shall be formulated and revised by the Pharmacopoeia Commission of the drug regulatory department of the State Council, and submitted to the drug regulatory department of the State Council for approval and promulgation.
放射性药品的检验由国务院药品监督管理部门公布的药品检验机构承担。
The inspection of radiopharmaceuticals shall be undertaken by drug inspection institutions published by the drug regulatory department of the State Council.
附 则
Supplementary Provisions
对违反本办法规定的单位或者个人，由县以上药品监督管理、卫生行政部门，按照《药品管理法》和有关法规的规定处罚。
Units or individuals that violate the provisions of these Measures shall be penalized by the drug regulatory department or health administrative department at or above the county level in accordance with the Drug Administration Law and relevant regulations.
本办法自发布之日起施行。
These Measures shall come into force as of the date of promulgation.