放射性药品管理办法 MEASURES FOR THE CONTROL OF RADIOACTIVE D_法律英语

放射性药品管理办法 MEASURES FOR THE CONTROL OF RADIOACTIVE D

文章来源：文章作者：发布时间：2007-04-19 01:15 字体： [大中小]　进入论坛

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国务院令第25号
（Promulgated¹ 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）
颁布日期：19890113 　实施日期：19890113 　颁布单位：国务院

　　Chapter I General Provisions

　　Article 1 These Measures are formulated³ to strengthen the control of radioactive drugs in accordance with Pharmaceutical⁴ 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 diagnosis⁵ or in radiotherapy.

　　Article 3 All units or individuals in the People's Republic of China are required to abide⁶ by these Measures when they are engaged in research work， production， business， transportation， consumption， examination， supervision⁷ and administration work related to radioactive drugs.

　　Article 4 The Ministry⁸ of Public Health is in charge of the supervisory and administrative⁹ 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 provincial¹⁰， autonomous¹¹ 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 technological¹² process， quality requirements， preclinico 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， toxicity¹³， nuclein animal dynamics¹⁴， radio specific 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 pharmaceuticals¹⁵.

　　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 License¹⁶.

　　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 stipulated¹⁷ in Article 5 of the Pharmaceutical Administration Law and that they must meet the essential standard of radio hygiene¹⁸ 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 expiration¹⁹ 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 specifications²⁰ 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 previously²¹ 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 qualified²² 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 inspection²³ 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 unified²⁴ 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 Business 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 jointly²⁵ 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 authorized²⁶ 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 promptly²⁷ 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， radio specific activity and packings.

　　The specifications must indicate the name of the producer， license number， batch²⁸ 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 postal²⁹ 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 undesirable³⁰ 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' excrement³¹） 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 entrusted³² to formulate² 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 Supplementary³³ Provisions

　　Article 29 Any unit or individual that violates these Measures shall be penalized³⁴ 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

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收听单词发音

1 promulgated
v.宣扬（某事物）( promulgate的过去式和过去分词 )；传播；公布；颁布（法令、新法律等）
参考例句：
Hence China has promulgated more than 30 relevant laws, statutes and regulations. 中国为此颁布的法律、法规和规章多达３０余项。来自汉英非文学 - 白皮书 The shipping industry promulgated a voluntary code. 航运业对自律守则进行了宣传。来自辞典例句

2 formulate
v.用公式表示；规划；设计；系统地阐述
参考例句：
He took care to formulate his reply very clearly.他字斟句酌，清楚地做了回答。 I was impressed by the way he could formulate his ideas.他陈述观点的方式让我印象深刻。

3 formulated
v.构想出( formulate的过去式和过去分词 )；规划；确切地阐述；用公式表示
参考例句：
He claims that the writer never consciously formulated his own theoretical position. 他声称该作家从未有意识地阐明他自己的理论见解。来自《简明英汉词典》 This idea can be formulated in two different ways. 这个意思可以有两种说法。来自《现代汉英综合大词典》

4 pharmaceutical
adj.药学的，药物的；药用的，药剂师的
参考例句：
She has donated money to establish a pharmaceutical laboratory.她捐款成立了一个药剂实验室。 We are engaged in a legal tussle with a large pharmaceutical company.我们正同一家大制药公司闹法律纠纷。

5 diagnosis
n.诊断，诊断结果，调查分析，判断
参考例句：
His symptoms gave no obvious pointer to a possible diagnosis.他的症状无法作出明确的诊断。 The engineer made a complete diagnosis of the bridge's collapse.工程师对桥的倒塌做一次彻底的调查分析。

6 abide
vi.遵守；坚持；vt.忍受
参考例句：
You must abide by the results of your mistakes.你必须承担你的错误所造成的后果。 If you join the club,you have to abide by its rules.如果你参加俱乐部，你就得遵守它的规章。

7 supervision
n.监督，管理
参考例句：
The work was done under my supervision.这项工作是在我的监督之下完成的。 The old man's will was executed under the personal supervision of the lawyer.老人的遗嘱是在律师的亲自监督下执行的。

8 ministry
n.(政府的)部；牧师
参考例句：
They sent a deputation to the ministry to complain.他们派了一个代表团到部里投诉。 We probed the Air Ministry statements.我们调查了空军部的记录。

9 administrative
adj.行政的，管理的
参考例句：
The administrative burden must be lifted from local government.必须解除地方政府的行政负担。 He regarded all these administrative details as beneath his notice.他认为行政管理上的这些琐事都不值一顾。

10 provincial
adj.省的，地方的；n．外省人，乡下人
参考例句：
City dwellers think country folk have provincial attitudes.城里人以为乡下人思想迂腐。 Two leading cadres came down from the provincial capital yesterday.昨天从省里下来了两位领导干部。

11 autonomous
adj.自治的；独立的
参考例句：
They proudly declared themselves part of a new autonomous province.他们自豪地宣布成为新自治省的一部分。 This is a matter that comes within the jurisdiction of the autonomous region.这件事是属于自治区权限以内的事务。

12 technological
adj.技术的；工艺的
参考例句：
A successful company must keep up with the pace of technological change.一家成功的公司必须得跟上技术变革的步伐。 Today,the pace of life is increasing with technological advancements.当今，随着科技进步，生活节奏不断增快。

13 toxicity
n.毒性，毒力
参考例句：
The hoarse grunt or squeal is characteristic of toxicity.嘶哑的哼声和叫声是中毒的特征。 Dieldrin is related to aldrin,and its toxicity to earthworms is similar.狄氏剂与艾氏剂有关，对蚯蚓的毒性是相似的。

14 dynamics
n.力学，动力学，动力，原动力；动态
参考例句：
In order to succeed,you must master complicated knowledge of dynamics.要取得胜利，你必须掌握很复杂的动力学知识。 Dynamics is a discipline that cannot be mastered without extensive practice.动力学是一门不做大量习题就不能掌握的学科。

15 pharmaceuticals
n.医药品；药物( pharmaceutical的名词复数 )
参考例句：
the development of new pharmaceuticals 新药的开发 The companies are pouring trillions of yen into biotechnology research,especially for pharmaceuticals and new seeds. 这些公司将大量资金投入生物工艺学研究，尤其是药品和新种子方面。来自《简明英汉词典》

16 license
n.执照，许可证，特许；v.许可，特许
参考例句：
The foreign guest has a license on the person.这个外国客人随身携带执照。 The driver was arrested for having false license plates on his car.司机由于使用假车牌而被捕。

17 stipulated
vt.& vi.规定；约定adj.[法]合同规定的
参考例句：
A delivery date is stipulated in the contract. 合同中规定了交货日期。 Yes, I think that's what we stipulated. 对呀，我想那是我们所订定的。来自辞典例句

18 hygiene
n.健康法，卫生学（a.hygienic）
参考例句：
Their course of study includes elementary hygiene and medical theory.他们的课程包括基础卫生学和医疗知识。 He's going to give us a lecture on public hygiene.他要给我们作关于公共卫生方面的报告。

19 expiration
n.终结，期满，呼气，呼出物
参考例句：
Can I have your credit card number followed by the expiration date?能告诉我你的信用卡号码和它的到期日吗? This contract shall be terminated on the expiration date.劳动合同期满，即行终止。

20 specifications
n.规格；载明；详述；（产品等的）说明书；说明书( specification的名词复数 )；详细的计划书；载明；详述
参考例句：
Our work must answer the specifications laid down. 我们的工作应符合所定的规范。来自《简明英汉词典》 This sketch does not conform with the specifications. 图文不符。来自《现代汉英综合大词典》

21 previously
adv.以前，先前（地）
参考例句：
The bicycle tyre blew out at a previously damaged point.自行车胎在以前损坏过的地方又爆开了。 Let me digress for a moment and explain what had happened previously.让我岔开一会儿，解释原先发生了什么。

22 qualified
adj.合格的，有资格的，胜任的，有限制的
参考例句：
He is qualified as a complete man of letters.他有资格当真正的文学家。 We must note that we still lack qualified specialists.我们必须看到我们还缺乏有资质的专家。

23 inspection
n.检查，审查，检阅
参考例句：
On random inspection the meat was found to be bad.经抽查，发现肉变质了。 The soldiers lined up for their daily inspection by their officers.士兵们列队接受军官的日常检阅。

24 unified
(unify 的过去式和过去分词)；统一的；统一标准的；一元化的
参考例句：
The teacher unified the answer of her pupil with hers. 老师核对了学生的答案。 The First Emperor of Qin unified China in 221 B.C. 秦始皇于公元前221年统一中国。

25 jointly
ad.联合地，共同地
参考例句：
Tenants are jointly and severally liable for payment of the rent. 租金由承租人共同且分别承担。 She owns the house jointly with her husband. 她和丈夫共同拥有这所房子。

26 authorized
a.委任的，许可的
参考例句：
An administrative order is valid if authorized by a statute.如果一个行政命令得到一个法规的认可那么这个命令就是有效的。

27 promptly
adv.及时地，敏捷地
参考例句：
He paid the money back promptly.他立即还了钱。 She promptly seized the opportunity his absence gave her.她立即抓住了因他不在场给她创造的机会。

28 batch
n.一批(组，群)；一批生产量
参考例句：
The first batch of cakes was burnt.第一炉蛋糕烤焦了。 I have a batch of letters to answer.我有一批信要回复。

29 postal
adj.邮政的，邮局的
参考例句：
A postal network now covers the whole country.邮路遍及全国。 Remember to use postal code.勿忘使用邮政编码。

30 undesirable
adj.不受欢迎的，不良的，不合意的，讨厌的；n.不受欢迎的人，不良分子
参考例句：
They are the undesirable elements among the employees.他们是雇员中的不良分子。 Certain chemicals can induce undesirable changes in the nervous system.有些化学物质能在神经系统中引起不良变化。

31 excrement
n.排泄物，粪便
参考例句：
The cage smelled of excrement.笼子里粪臭熏人。 Clothing can also become contaminated with dust,feathers,and excrement.衣着则会受到微尘、羽毛和粪便的污染。

32 entrusted
v.委托，托付( entrust的过去式和过去分词 )
参考例句：
He entrusted the task to his nephew. 他把这任务托付给了他的侄儿。 She was entrusted with the direction of the project. 她受委托负责这项计划。来自《简明英汉词典》

33 supplementary
adj.补充的，附加的
参考例句：
There is a supplementary water supply in case the rain supply fails.万一主水源断了，我们另外有供水的地方。 A supplementary volume has been published containing the index.附有索引的增补卷已经出版。

34 penalized
对…予以惩罚( penalize的过去式和过去分词 )；使处于不利地位
参考例句：
You will be penalized for poor spelling. 你拼写不好将会受到处罚。 Team members will be penalized for lateness. 队员迟到要受处罚。

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