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| Order of the State Council of the People's Republic of China | | 中华人民共和国国务院令 |
(No. 25) | |
（第２５号） |
The Measures for the Control of Radioactive Drugs are hereby issued and shall come into force as of the date of promulgation. | |
现发布《放射性药品管理办法》，自发布之日起施行。 |
Prime Minister: Li Peng | |
总理 李鹏 |
January 13, 1989 | |
１９８９年１月１３日 |
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS | |
放射性药品管理办法 |
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| CHAPTER I GENERAL PROVISIONS | | 第一章 总则 |
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| 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). | | 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。 |
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| Article 2. "Radioactive drugs" refer to any forms of radionuclide or their tagged drugs that are used for clinical diagnosis or in radiotherapy. | | 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。 |
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| 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. | | 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。 |
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| 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. | | 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。 |
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| CHAPTER II EXAMINATION AND APPROVAL FOR THE DEVELOPMENT AND CLINICAL RESEARCH OF NEW RADIOACTIVE DRUGS | | 第二章 放射性新药的研制、临床研究和审批 |
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| 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. | | 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。 |
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| Article 6. The development of a new kind of radioactive drug includes the research work in its technological process, quality requirements, preclinical-pharmacological 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, radio-specific activity, dosage, pharmaceutical forms and stability of that radioactive drug. | | 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。 |
Furthermore, the research unit must make a study of radio-immunity analysis container with respect to its scalability, range, specificity, accuracy, precision and stability. | |
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、稳定性等方法的研究。 |
New kinds of radioactive drugs shall be classified in accordance with the provisions for the examination and approval of new pharmaceuticals. | |
放射性新药的分类，按新药审批办法的规定办理。 |
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| 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. | | 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。 |
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| 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. | | 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。 |
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| 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. | | 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。 |
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| CHAPTER III THE PRODUCTION, SALES, IMPORT AND EXPORT OF RADIOACTIVE DRUGS | | 第三章 放射性药品的生产、经营和进出口 |
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| 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. | | 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。 |
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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.
．．．．．． | | 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。
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