Administrative Measures for the Control of Radioactive Drugs (Revised in 2011)
Administrative Measures for the Control of Radioactive Drugs (Revised in 2011)
Administrative Measures for the Control of Radioactive Drugs (Revised in 2011)
Order of the State Council of the People's Republic of China No. 588
January 8, 2011
(Promulgated by Order of the State Council of the People's Republic of China No. 25 on January 13, 1989, and revised according to the Decision of the State Council on Abolishing and Revising Certain Administrative Regulations on January 8, 2011)
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.
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