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. Upon approval by the department in charge of supervision and administration of drugs under the State Council, the clinical research shall be conducted at the institution for clinical drug test designated by the department in charge of supervision and administration of drugs under the State Council.

Article 7 After completion of clinical study of a newly developed radioactive drug, the research unit must submit an application to the department in charge of supervision and administration of drugs under the State Council for examination and approval.
The latter shall consult the competent department of science, technology and industry for national defense under 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 department in charge of supervision and administration of drugs under the State Council. After examination and verification, the department in charge of supervision and administration of drugs under the State Council shall issue them document of approval.

Chapter III The Production, Sales, Import and Export of Radio- active Drugs

Article 9 The State shall, based on the needs, formulate a reasonable layout for enterprises producing radioactive drugs.

Article 10 The establishment of a manufacturer or an operating enterprise of radioactive drugs shall meet the provisions of the Drug Administration Law, meet the national provisions and criteria concerning the safety of and protection from radioisotopes, and the approval formalities in the evaluation document of environmental influence shall be performed; upon the review and consent by the competent department of science, technology and industry for national defense under the State Council, as well as the examination and approval by the department in charge of supervision and administration of drugs under the State Council, the License for Operating Enterprises of Radioactive Drugs shall be issued by the department in charge of supervision and administration of drugs of the province, autonomous region or municipality directly under the Central Government for the establishment of the manufacturer of radioactive drugs; if the establishment of an operating enterprise of radioactive drugs is reviewed by the department in charge of supervision and administration of drugs under the State Council and subject to the opinion of the competent department of science, technology and industry for national defense under the State Council, the License for Operating Enterprises of Radioactive Drugs shall be issued by the department in charge of supervision and administration of drugs of the province, autonomous region or municipality directly under the Central Government. Any manufacturer or operating enterprise of radioactive drugs without a license shall not produce or sell radioactive drugs.

Article 11 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 drug supervision and administration department which shall, in accordance with Article 10 of these Provisions, issue them a new license.

Article 12 For production of radioactive drugs by a radioactive drug manufacturer subject to existing national criteria, such production shall be reviewed and approved by the department in charge of supervision and administration of drugs under the State Council after seeking the opinion of the competent department of science, technology and industry for national defense under the State Council, with the approval document No. In the case of any change in the production process route and drug criteria approved by the department in charge of supervision and administration of drugs under the State Council, the manufacturing unit must submit a supplementary application according to the original approval procedures and may manufacture the drugs upon the approval by the department in charge of supervision and administration of drugs under the State Council.

Article 13 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 14 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 quality 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.
Any drug containing a short half-life period radionuclide, which is reviewed and approved by the department in charge of supervision and administration of drugs under the State Council may leave the factory while such drug is being tested. However, when it is discovered to conform to the national drug criteria, the manufacturer of such drug shall immediately stop the production and sales thereof, notify the units using such drug of stopping the use, and report such circumstance to competent departments in charge of drug supervision and administration, health administration, science, technology and industry for national defense under the State Council at the same time.

Article 15 The units manufacturing and operating radioactive drugs and medical treatment units subject to the License for Manufacture of Radioactive Drugs and the License for Operating Enterprises of Radioactive Drugs issued by the departments in charge of supervision and administration of drugs of the provinces, autonomous regions or municipalities directly under the Central Government, as well as medical treatment units subject to the License for the Use of Radioactive Drugs issued by the departments in charge of supervision and administration of drugs of the provinces, autonomous regions or municipalities directly under the Central Government, shall launch the purchase and sales of radioactive drugs.

Article 16 Imported radioactive drugs must meet the drug criteria or other officinal requirements of China, and the registration certificates for imported drugs shall be acquired in accordance with the Drug Administration Law.
The import and export formalities shall be handled in accordance with the national provisions concerning foreign trade, safety of and protection from radioisotopes for the import and export of radioactive drugs.

Article 17 Radioactive drugs may be imported only if they pass the sampling test conducted by the drug inspection institution designated by the department in charge of supervision and administration of drugs under the State Council.
For drugs containing a short half-life period radionuclide upon the review and approval by the department in charge of supervision and administration of drugs under the State Council, they may be put into use while they are subject to an import inspection provided that the safe use thereof can be ensured. If an import inspection unit discovers that drugs are not qualified, it shall notify the units using such drugs to stop their use and report such circumstance to the competent departments in charge of drug supervision and administration, health administration, science, technology and industry for national defense under the State Council.

Chapter IV The Packaging and Shipment of Radioactive Drugs

Article 18 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, 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, specific activity and packings.

Article 19 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 Usage of Radioactive Drugs

Article 20 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 21 The use of radioactive drugs by a medical treatment unit shall meet the State provisions on safety of and protection from radioisotopes. The department in charge of supervision and administration of drugs of the province, autonomous region or municipality directly under the Central Government of the place where the medical treatment unit is located shall, based on the level of nuclear medical treatment technicians and the equipment conditions of such unit, issue the License for the Use of Radioactive Drugs of the corresponding grade, without which such unit shall not use radioactive drugs on a clinical basis.
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 22 The preparation or use of radioactive preparations shall meet the relevant provisions of the Drug Administration Law and the implementing rules thereof.

Article 23 A medical treatment unit holding the License for the Use of Radioactive Drugs must be responsible for the clinical quality test of the used radioactive drugs, collection of adverse reactions thereof, etc., and shall regularly report the foregoing work to the department of drug supervision and administration or that of the health administrative department of the place where such unit is located. After such reports are collected by the department of drug supervision and administration or that of the health administrative department of the province, autonomous region or municipality directly under the Central Government, they will be respectively submitted to the department of drug supervision and administration or that of the health administrative department under the State Council.

Article 24 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 25 The Pharmacopoeia Commission under the department in charge of supervision and administration of drugs under the State Council is entrusted to formulate and revise the State standards for radioactive drugs and then submit it to the department in charge of supervision and administration of drugs under the State Council for examination and approval before it is promulgated.

Article 26 The inspection of radioactive drugs shall be undertaken by the drug inspection institution promulgated by the department in charge of supervision and administration of drugs under the State Council.

Chapter VII Supplementary Provisions

Article 27 In regard to any unit or individual violating these Measures, the administrative department in charge of supervision and administration of drugs or health shall impose a penalty thereon in accordance with the Drug Administration Law and relevant regulations.

Article 28 These Measures shall go into effect as of the date of promulgation.