Measures for the Administration of Radioactive Pharmaceuticals (2017 Revision)

Measures for the Administration of Radioactive Pharmaceuticals (2017 Revision) Measures for the Administration of Radioactive Pharmaceuticals (Promulgated by Order No. 25 of the State Council of the People's Republic of China on January 13, 1989; revised for the first time in accordance with the Decision of the State Council on Abolishing and Amending Some Administration Regulations on January 8, 2011; revised for the second time in accordance with the Decision of the State Council to Amend and Repeal 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 drug supervision administrative department of the State Council shall be responsible for the national supervision and administration of radioactive pharmaceuticals. The administrative department of science, technology and industry for national defense of the State Council shall be responsible for the relevant administration of radioactive pharmaceuticals according to its functions. The environmental protection department of the State Council shall be responsible for the supervision and administration of the radiation safety and protection in relation to radioactive pharmaceuticals. 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, 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. 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 issued by the drug supervision administrative department of the State Council on drug registration. Article 6 Before the clinical test or validation of new radioactive drugs developed by the research entity, an application shall be filed with the drug supervision administrative department of the State Council, with materials and specimens submitted as required, and clinical study shall be conducted at the drug clinical test institution designated by the drug supervision administrative department of the State Council after it approves the application. Article 7 After completion of clinical study of a newly developed radioactive drug, the research unit must submit an application to the drug supervision administrative department of the State Council for examination and approval. The latter shall consult the administrative department of science, technology and industry for national defense of the State Council before granting a New Drug License. Article 8 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 drug supervision administrative department of the State Council. After examination and verification, the Ministry of Public Health shall issue them document of approval. Chapter III The Production, Sales, Import and Export of Radioactive Drugs Article 9 The state shall, as needed, make rational distribution of manufacturers of radioactive pharmaceuticals. Article 10 To form a production or distribution enterprise of radioactive pharmaceuticals, the conditions prescribed in the Pharmaceutical Administration Law shall be met, the provisions and st......