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

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国务院令第25号
(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)
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 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, 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, toxicity, nuclein animal dynamics, 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 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 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 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, radio specific 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.

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