放射性药品管理办法(附英文)
[颁布方] 国务院
[颁布日期] 19890113
[实施日期] 19890113
[内容]
第一章 总 则
第一条 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。
第二条 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。
第三条 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。
第四条 卫生部主管全国放射性药品监督管理工作。能源部主管放射性药品生产、经营管理工作。
第二章 放射性新药的研制、临床研究和审批
第五条 放射性新药是指我国首次生产的放射性药品。药品研制单位的放射性新药年度研制计划，应当报送能源部备案，并报所在地的省、自治区、直辖市卫生行政部门，经卫生行政部门汇总后，报卫生部备案。
第六条 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。
研制单位对放射免疫分析药盒必须进行可测限度、范围、待异性、准确度、精密度、稳定性等方法学的研究。
放射性新药的分类，按新药审批办法的规定办理。
第七条 研制单位研制的放射性新药，在进行临床试验或者验证前，应当向卫生部提出申请，按新药审批办法的规定报送资料及样品，经卫生部审批同意后，在卫生部指定的医院进行临床研究。
第八条 研制单位在放射性新药临床研究结束后，向卫生部提出申请，经卫生部审核批准，发给新药证书。卫生部在审核批准时，应当征求能源部的意见。
第九条 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）向卫生部提出生产该药的申请，并提供样品，由卫生部审核发给批准文号。
第三章 放射性药品的生产、经营和进出口
第十条 放射性药品生产、经营企业，必须向能源部报送年度生产、经营计划，并抄报卫生部。
第十一条 国家根据需要，对放射性药品实行合理布局，定点生产。申请开办放射性药品生产、经营的企业，应征得能源部的同意后，方可按照有关规定办理筹建手续。
第十二条 开办放射性药品生产、经营企业，必须具备《药品管理法》第五条规定的条件，符合国家的放射卫生防护基本标准，并履行环境影响报告的审批手续，经能源部审查同意，卫生部审核批准后，由所在省、自治区、直辖市卫生行政部门发给《放射性药品生产企业许可证》、《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。
第十三条 《放射性药品生产企业许可证》、《放射性药品经营企业许可证》的有效期为五年，期满前六个月，放射性药品生产、经营企业应当分别向原发证的卫生行政部门重新提出申请，按第十二条审批程序批准后，换发新证。
第十四条 放射性药品生产企业生产已有国家标准的放射性药品，必须经卫生部征求能源部意见后审核批准，并发给批准文号。凡是改变卫生部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经卫生部批准后方能生产。
第十五条 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。
第十六条 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。
经卫生部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，同时报告卫生部和能源部。
第十七条 放射性药品的生产、供销业务由能源部统一管理。放射性药品的生产、经营单位和医疗单位凭省、自治区、直辖市卫生行政部门发给的《放射性药品生产企业许可证》、《放射性药品经营企业许可证》，医疗单位凭省、自治区、直辖市公安、环保和卫生行政部门联合发给的《放射性药品使用许可证》，申请办理订货。
第十八条 放射性药品的进出口业务，由对外经济贸易部指定的单位，按照国家有关对外贸易的规定办理。
进出口放射性药品，应当报卫生部审批同意后，方得办理进出口手续。
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。
第十九条 进口放射性药品，必须经中国药品生物制品检定所或者卫生部授权的药品检验所抽样检验；检验合格的，方准进口。
对于经卫生部审核批准的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，并报告卫生部和能源部。
第四章 放射性药品的包装和运输
第二十条 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。
标签必须注明药品品名、放射性比活度、装量。
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。
第二十一条 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。
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。
第二十二条 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枝术培训的技术人员。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。
第二十三条 医疗单位使用放射性药品，必须符合国家放射性同位素卫生防护管理的有关规定。所在地的省、自治区、直辖市的公安、环保和卫生行政部门，应当根据医疗单位核医疗技术人员的水平、设备条件，核发相应等级的《放射性药品使用许可证》，无许可证的医疗单位不得临床使用放射性药品。
《放射性药品使用许可证》有效期为五年，期满前六个月，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。
第二十四条 持有《放射性药品使用许可证》的医疗单位，在研究配制放射性制剂并进行临床验证前，应当根据放射性药品的持点，提出该制剂的药理、毒性等资料，由省、自治区、直辖市卫生行政部门批准，并报卫生部备案。该制剂只限本单位内使用。
第二十五条 持有《放射性药品使用许可证》的医疗单位，必须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，并定期向所在地卫生行政部门报告。由省、自治区、直辖市卫生行政部门汇总后报卫生部。
第二十六条 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。
第五章 放射性药品标准和检验
第二十七条 放射性药品的国家标准，由卫生部药典委员会负责制定和修订，报卫生部审批颁发。
第二十八条 放射性药品的检验由中国药品生物制品检定所或者卫生部授权的药品检验所承担。
第六章 附 则
第二十九条 对违反本办法规定的单位或者个人，由县以上卫生行政部门，按照《药
品管理法》和有关法规的规定处罚。
第三十条 本办法由卫生部负责解释。
第三十一条 本办法自发布之日起施行。
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS
Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE PEOPLE’S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7) which is compiled by the Brueau of Legislative Affairs of the State Council of the People’s Republic of China, and is published by the China Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.
Whole Document (法规全文)
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS (Promulgated by Decree No. 25 of the State Council of the People’s Republic of China on January 13, 1989 and effective as of the date of promulgation)
Chapter I General Provisions
Article 1
These Measures are formulated to strengthen the control of radioactive drugs in accordance with Pharmaceutical Administration Law of the People’s Republic of China (hereinafter referred to as the Pharmaceutical Administration Law)
Article 2
"Radioactive drugs" refer to any forms of radionuclide or their tagged
drugs that are used for clinical diagnosis or in radiotherapy.
Article 3
All units or individuals in the People’s Republic of China are required to
abide by these Measures when they are engaged in research work, production, business, transportation, consumption, examination, supervision and administration work related to radioactive drugs.
Article 4
The Ministry of Public Health is in charge of the supervisory and administrative work of radioactive drugs while the Ministry of Energy is in charge of the administration work concerning the production and sale of radioactive drugs.
Chapter II Examination and Approval for the Development and Cli- nical Research of New Radioactive Drugs
Article 5
"New radioactive drugs" refer to those radioactive drugs that are made in China for the first time. The annual plan of any drug research units for the development of new radioactive drugs must be submitted to both the Ministry of Energy for the record and to the health administration department at the provincial, autonomous regional or municipal (directly under the Central Government) level. Then an itemized plan made by the latter shall be presented to the Ministry of Public Health for the record.
Article 6
The development of a new kind of radioactive drug includes the research work in its technological process, quality requirements, preclinicopharmacological study and clinical study; The research unit, when designing the technological process for a new drug, must study the physical and chemical properties, purity (including
pureness of radionuclide), testing method, pharmacology, toxicity, nuclein animal dynamics, radiospecific activity, dosage, pharmaceutical forms and stability of that radioactive drug. Furthermore, the research unit must make a study of radio-immunity analysis container with respect to its scalability, range, specificity, accuracy, precision and stability. New kinds of radioactive drugs shall be classified in accordance with the provisions for the examination and approval of new pharmaceuticals.
Article 7
Before the newly developed radioactive drug is put to clinical test or
verification, an application together with the data and sample must be submitted to the Ministry of Public Health in accordance with the provisions for the examination and approval of new pharmaceuticals. The newly developed radioactive drug may be used for clinical study at an appointed hospital only after its application has been examined and approved by the Ministry of Public Health.
Article 8
After completion of clinical study of a newly developed radioactive drug, the research unit must submit an application to the Ministry of Public Health for examination and approval. The latter shall consult the Ministry of Energy before granting a New Drug
License.
Article 9
Before a newly developed radioactive drug is put to production, the production unit or the research unit that holds a license for the production of radioactive drugs must submit an application together with a copy of New Drug License and sample to the Ministry of Public Health. After examination and verification, the Ministry of Public Health shall issue them document of approval.
Chapter III The Production, Sales, Import and Export of Radio- active Drugs
Article 10
The enterprises that produce or sell radioactive drugs are required to submit their production plan and business plan to the Ministry of Energy and a duplicate to the Ministry of Public Health.
Article 11
The State shall, according to the actual conditions, make sure that radioactive drugs be produced at designated pharmaceutical factories which shall be located rationally over the country. Applications for the setting up of any enterprises to produce or sell radioactive drugs must be approved by the Ministry of Energy before the preparations start in accordance with related provisions.
Article 12
Requirements for the setting up of enterprises to produce or sell
radioactive drugs are that they must have the necessary conditions as stipulated in Article 5 of the Pharmaceutical Administration Law and that they must meet the essential standard of radio hygiene protection set by the State. They are also required to submit a report on environment impact to the Ministry of Energy and the Ministry of Public Health for examination and approval and then the health administration department in their province, autonomous region or municipality directly under the Central Government shall issue them "License for the Production Enterprise of Radioactive Drugs", "License for the Business Enterprise of Radioactive
Drugs". No enterprises without the license shall be permitted to engage in the production or sale of radioactive drugs.
Article 13
The term of validity of "License for the Production Enterprise of Radioactive Drugs" and "License for the Business Enterprise of Radioactive Drugs" is five years. If needed, the enterprises engaged in the production or sale of radioactive drugs shall make a new application six months before the expiration to the health administration department which shall, in accordance with Article 12 of these Provisions, issue them a new license.
Article 14
Before an approved pharmaceutical enterprise produces radioactive drugs with specifications already set by the State, it must forward an application which has to be examined and approved by the Ministry of Public Health in conjunction with the Ministry of Energy. If any changes in the technological process and specifications of the drugs previously approved by the Ministry of Public Health are to be made, the pharmaceutical factory shall be required to go through the same procedures for approval.
Article 15
The production and business enterprises of radioactive drugs are required to employ technical personnel who are qualified for the work and to have safety and protection facilities as well as waste gas, liquid and material disposal facilities. They must also have a strict quality control system.
Article 16
The production and business enterprises of radioactive drugs are required to set up quality inspection offices. The entire process of production must be put under strict qualify control and inspection. All radioactive drugs are subject to quality testing. Only the products that meet the State pharmaceutical standard shall be allowed to be shipped out from the factories. Products that are not up to the standard are not allowed out of the factory. As for the drugs with short half-life
radionuclide previously approved by the Ministry of Public Health, they may be shipped out from the factory while having sample testing. If the drugs are found to be below the State pharmaceutical standard, the factory must stop the production and sale of the drugs immediately and inform consuming units to stop using the drugs without delay. A report about the case must be submitted to both the Ministry of Public Health and the Ministry of Energy.
Article 17
The production, supply and sale of radioactive drugs are under the unified administration of the Ministry of Energy. When ordering these stuff, the pharmaceutical factory must furnish a License for the Production Enterprise of Radioactive Drugs while the business unit must present a License for the usiness Enterprise of Radioactive Drugs issued by the health administration department at the provincial, autonomous regional or municipal (directly under the Central Government) level. As for the medical treatment unit, they must order
these drugs with a License for the Use of Radioactive Drugs jointly issued by the public security department, the environment protection department and health administration department at the provincial, autonomous regional or the municipal (directly under the Central Government) level.
Article 18
The import and export business of radioactive drugs shall be handled by the units appointed by the Ministry of Foreign Economic Relations and Trade in accordance with the State provisions related to foreign trade. Prior to the import or export of radioactive drugs, an application must be made and be examined and approved by the Ministry of Public Health. Imported radioactive drugs are required to meet the State standards for pharmaceuticals or other medical requirements.
Article 19
Imported radioactive drugs are subject to sample examination by the State Administration for the Inspection and Testing of Pharmaceuticals and Biological Products or by an inspection and testing institution of pharmaceuticals authorized by the Ministry of Public Health. Only those drugs that have met the State standards are allowed to be imported. As for the drugs with short half-life radionuclide previously approved by the Ministry of Public Health, they may be put to use upon being shipped in while having import inspection. If the import inspection unit finds the quality of imported drugs not up to the standard, they must inform the consuming units promptly to stop using the drugs. A report about the quality problem must be submitted to both the Ministry of Public Health
and the Ministry of Energy.
Chapter IV The Packaging and Shipment of Radioactive Drugs
Article 20
The packaging of radioactive drugs must be safe and reliable, and up to the standards for the quality requirements of radioactive drug. There must be protection devices that will match different radio dosages. The packaging is required to consist of packing and inner packaging. There must be trade mark, label, specifications and marker of radioactive drugs on the packing and a label on the inner packaging. On the label there must be name of the drug, radiospecific activity and packings.
The specifications must indicate the name of the producer, license number, batch number, main composition, date of manufacture, half-life of radionuclide, indications, administration, dosage, contraindication, expiry date and precautions in addition to name of the drug, radioapecific activity and packings.
Article 21
The shipment of radioactive drugs shall be handled in accordance with the rules formulated by the State transportation and postal departments. No unit or person shall be allowed to carry along radioactive drugs on any means of public transportation.
Chapter V The Use of Radioactive Drugs
Article 22
If a medical treatment unit desires to set up a radiologic department or a radioisotope department, it is required to employ technical personnel who are qualified for radiotherapeutic work after special technical training. Without prior technical training no personnel shall be allowed to use the drugs in radiotherapy.
Article 23
When a medical treatment unit uses radioactive drugs, it must observe the
rules formulated by the State concerning radioisotope hygiene and protection. The health administration department, the public security department and the environment protection department at provincial, autonomous regional or municipal (directly under the Central Government) level shall issue a certain grade of License for the Use of Radioactive Drugs according to technical skill and professional level of the radiological personnel and equipment of the medical treatment unit. No medical treatment unit without a license is allowed to use radioactive
drugs clinically. The term of validity of a License for the Use of Radioactive Drugs is 5 years. If needed, the medical treatment unit must make a new application 6
months before the expiration of its license to the health administration department which, after examination and verification shall issue it a new license.
Article 24
Before a medical treatment unit holding a License for the Use of Radioactive Drugs starts the preparation of any forms of radioactive drug for clinical use, it is required to submit an application with the data concerning pharmacology and toxicity of the radioactive drug, according to the characteristics of the radioactive drug, to the health administration department at the provincial, autonomous regional or municipal (directly under the Central Government) level for approval and to the Ministry of Public Health for the record. That form of radioactive drug can be used
only in the medical treatment unit.
Article 25
The medical treatment units that hold a License for the Use of Radioactive Drugs are required to conduct clinical quality testing of the radioactive drugs and find out their undesirable reactions and submit regular reports to the health administration department. The health administration department at the provincial, autonomous regional or municipal (directly under the Central Government) level shall then present an itemized report to the Ministry of Public Health.
Article 26
Waste material of radioactive drugs (including patients’ excrement) must
be properly disposed of in accordance with the State regulations.
Chapter VI The Standards for Radioactive Drugs and Their Testing
Article 27
The Pharmacopoeia Commission under the Ministry of Public Health is entrusted to formulate and revise the State standards for radioactive drugs and then submit it to the Ministry of Public Health for examination and approval before it is promulgated.
Article 28
The State Administration for the Inspection and Testing of Pharmaceuticals and Biological Products or an inspection and testing institution of pharmaceuticals authorized by the Ministry of Public Health is entrusted to inspect and examine radioactive drugs.
Chapter VII Supplementary Provisions
Article 29
Any unit or individual that violates these Measures shall be penalized by the health administration department at or above the county level in accordance with the Pharmaceutical Administration Law and other rules and regulations.
Article 30
The right to interpret these Measures resides in the Ministry of Public Health.
Article 31
These Measures shall go into effect as of the date of promulgation.
（编辑:youke）
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