China Food and Drug Regulatory Information Network
 
contant us
Home Market Overview Conferences BBS
International Exchange & Forums
Introduction to E-newsletter
Profile of Industry
Laws & Regulations - Drugs - Regulations for the Control of Radioactive Pharmaceuticals
Regulations for the Control of Radioactive Pharmaceuticals
 
2012/3/20 14:17:12Source: Hits:

Chapter I General Provisions
Article 1 These Regulations are formulated to strengthen the control of radioactive pharmaceuticals in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law).
Article 2 "Radioactive pharmaceuticals" refers to any forms of radionuclide or their labeled drugs that are used for clinical diagnosis or therapy.
Article 3 Any organization or individual in the People's Republic of China shall abide by these Regulations when they are engaged in research, production, distribution, transportation, use, testing and regulation with respect to radioactive pharmaceuticals.
Article 4 The Ministry of Health is in charge of regulation of radioactive pharmaceuticals while the Ministry of Energy is in charge of production and distribution of radioactive pharmaceuticals.

Chapter II  Research, Clinical Trial, Approval of New Radioactive Pharmaceuticals
Article 5 "New radioactive pharmaceuticals" refers to radioactive pharmaceuticals that are produced in China for the first time. The annual plan of a drug research organization for the development of new radioactive pharmaceuticals must be submitted to both the Ministry of Energy for the record and to the health administrative department of a province, autonomous region or municipality directly under the Central Government, where the research organization is located. An annual plan collected and summarized by the health administrative department shall be submitted to the Ministry of Health for the record.
Article 6 The research of a new radioactive drug includes its production process, specifications, preclinical pharmacological study and clinical study. The research institution, when designing the production process for a new radioactive drug, shall study the physical and chemical properties, purity (including purity of the nuclide), testing method, pharmacology, toxicology, animal pharmacokinetics, radio specific activity, dosage, dosage forms and stability of the radioactive drug.
For a radio-immunity-analysis kit, the research institution shall make methodology studies on its scalability, range, specificity, accuracy, precision and stability.
New radioactive pharmaceuticals shall be classified in accordance with the provisions for approval of new drugs.
Article 7 Before a new radioactive drug is put to clinical trial or verification, the research institution shall submit an application together with the data and sample to the Ministry of Health in accordance with the provisions for approval of new drugs. Clinical study shall be conducted for the new radioactive drug at a hospital appointed by the Ministry of Health after approval.
Article 8 After completion of clinical study of a new radioactive drug, the research institution shall submit an application to the Ministry of Health which shall issue a new drug certificate after examination and approval. The Ministry of Health shall consult the Ministry of Energy when making the examination and approval.
Article 9 Before a new radioactive drug is put into production, the manufacturer or the research institution that holds a manufacturing certificate for a radioactive pharmaceutical shall submit an application with the counterpart of its New Drug Certificate to the Ministry of Health, and provide samples. The Ministry of Health shall issue an approval number after examination and verification.

Chapter III  Production, Distribution, Import and Export of Radioactive Pharmaceuticals
Article 10 A manufacturer or distributor of radioactive pharmaceuticals shall submit its annual production and distribution plans to the Ministry of Energy and copy to the Ministry of Health.
Article 11 The State shall, according to the actual needs, make rational arrangements for radioactive pharmaceuticals and locate production at designated places. An application for establishment of an enterprise to produce or distribute radioactive pharmaceuticals shall be approved by the Ministry of Energy before the procedure for construction preparation can be started in accordance with related provisions.
Article 12 An enterprise to be established for production or distribution of a radioactive drug shall possess the necessary conditions as prescribed in Article 15 of the Drug Administration Law, meet the basic health standards for radiological health protection set by the State, and undergo a review and approval procedure for environmental impact report. The local health administrative department of the province, autonomous region or municipality directly under the Central Government shall issue a Radioactive Drug Manufacturing Enterprise Certificate or Radioactive Drug Distribution Enterprise Certificate after the examination and agreement by the Ministry of Energy and review and approval by the Ministry of Public Health.  An enterprise without a Certificate shall not produce or distribute radioactive pharmaceuticals.
Article 13 The term of validity of a Radioactive Drug Manufacturing Enterprise Certificate or Radioactive Drug Distribution Enterprise Certificate is five years.  A radioactive drug manufacturer or distributor shall apply for a renewal to the original issuing health administrative department six months in advance based on the expiry date. The department shall conduct a review and approval process in accordance with Article 12 of the Regulations before the issuance of a new certificate. 
Article 14 Where a radioactive drug to be produced has an existing national standard, the Ministry of Health shall consult the Ministry of Energy before review and approval, and issue an approval number. Where there is any change to the production process and specifications which have been approved by the Ministry of Health, the drug manufacturer shall not start production until the Ministry of Health approves its application submitted in accordance with the original applying procedure.
Article 15 A radioactive drug manufacturer or distributor shall have professional technical personnel appropriate to production and distribution of radioactive pharmaceuticals, facilities for safety, protection as well as treatment of waste gas, rubbish and sewage, and a strict quality management system.
Article 16 A radioactive drug manufacturer or distributor shall establish a quality testing institution and strictly conduct quality control and testing during the entire production process. The product shall be subject to quality test before release. No product is allowed to be released unless it meets the national standard. Non-conforming products are not permitted to be released from factory.
A drug with short half-life radionuclide approved by the Ministry of Health may be released along with testing. Once its quality is found in non-compliance with the national standard, the manufacturer shall immediately suspend the production and sale, notify the user to stop using the product, and meanwhile report to the Ministry of Health and the Ministry of Energy.
Article 17 The production, supply and sale of radioactive pharmaceuticals are under the unified administration of the Ministry of Energy. A drug manufacturer, distributor and medical institution shall order radioactive pharmaceuticals in presence of its Radioactive Drug Manufacturing Enterprise Certificate or Radioactive Drug Distribution Enterprise Certificate issued by the health administrative department of the province, autonomous region or municipality directly under the Central Government; a medical institution shall present Radioactive Drug Use Permit issued jointly by the public security, environmental protection and health administrative departments of the province, autonomous region or municipality directly under the Central Government.
Article 18 The import and export business of radioactive pharmaceuticals shall be handled by the organizations appointed by the Ministry of Foreign Economic Relations and Trade in accordance with the State provisions on foreign trade.
Where a radioactive pharmaceutical is to be imported or exported, an application shall be submitted to the Ministry of Public Health, and the import or export procedures may be completed only after receiving the approval.
Radioactive pharmaceuticals to be imported must meet the national drug standards or other drug requirements.
Article 19 Importation of a radioactive pharmaceutical is subject to sample testing by the National Institute for Control of Pharmaceutical and Biological Products or by a drug testing institute authorized by the Ministry of Public Health. A drug is allowed to be imported

[1] [2] Next

Laws & Regulations more
Medical Devices more
CHINA CENTER FOR PHARMACEUTICAL INTERNATIONAL EXCHANGE