Administrative Measures for the Control of Radioactive Drugs (Revised in 2017)
Administrative Measures for the Control of Radioactive Drugs (Revised in 2017)
Administrative Measures for the Control of Radioactive Drugs (Revised in 2017)
Order of the State Council of the People's Republic of China No.676
March 1, 2017
(Promulgated by Order of the State Council of the People's Republic of China No. 25 on January 13, 1989; revised for the first time according to the Decision of the State Council on Abolishing and Revising Certain Administrative Regulations on January 8, 2011; and revised for the second time in accordance with the Decision of the State Council on Revising and Repealing Certain Administrative Regulations on March 1, 2017)
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 department in charge of supervision and administration of drugs under the State Council shall be responsible for the nationwide supervision and administration of radioactive drugs. The competent department of science, technology and industry for national defense under the State Council shall, according to its duties, be responsible for the administration related to radioactive drugs. The competent department of environmental protection under the State Council shall be responsible for the supervision and administration of radiation safety and protection with respect to radioactive drugs.
Chapter II Examination and Approval for the Development and Clinical Research of New Radioactive Drugs
Article 5 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.
The classification of new radioactive drugs shall be handled according to the provisions of the department in charge of supervision and administration of drugs under the State Council on drug registration.
Article 6 Before the clinical test or verification of any radioactive drug developed by a research unit, such unit shall apply to the department in charge of supervision and administration of drugs under the State Council and submit the materials and samples thereto as specified.
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Order of the State Council of the People's Republic of China No.676
March 1, 2017
(Promulgated by Order of the State Council of the People's Republic of China No. 25 on January 13, 1989; revised for the first time according to the Decision of the State Council on Abolishing and Revising Certain Administrative Regulations on January 8, 2011; and revised for the second time in accordance with the Decision of the State Council on Revising and Repealing Certain Administrative Regulations on March 1, 2017)
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 department in charge of supervision and administration of drugs under the State Council shall be responsible for the nationwide supervision and administration of radioactive drugs. The competent department of science, technology and industry for national defense under the State Council shall, according to its duties, be responsible for the administration related to radioactive drugs. The competent department of environmental protection under the State Council shall be responsible for the supervision and administration of radiation safety and protection with respect to radioactive drugs.
Chapter II Examination and Approval for the Development and Clinical Research of New Radioactive Drugs
Article 5 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.
The classification of new radioactive drugs shall be handled according to the provisions of the department in charge of supervision and administration of drugs under the State Council on drug registration.
Article 6 Before the clinical test or verification of any radioactive drug developed by a research unit, such unit shall apply to the department in charge of supervision and administration of drugs under the State Council and submit the materials and samples thereto as specified.
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