The State Food and Drug Administration recently issued the "Opinions on Reforming and Improving the Management System for the Evaluation and Approval of Radioactive Drugs" (hereinafter referred to as the "Opinions"), proposing to encourage the development and application of radioactive drugs based on clinical value. Radiopharmaceuticals play a particularly important role in the diagnosis and treatment of malignant tumors, cardiovascular and cerebrovascular diseases, central nervous system disease, etc., mainly including radionuclide preparations, radionuclide labeled drugs, etc. In recent years, significant progress has been made in the research and application of radioactive drugs, but there is still a certain gap between them and the international advanced level. The Opinion proposes to encourage drug research and development to meet clinical needs. Encourage clinical value oriented innovation in radioactive drugs, and encourage the import and registration of original radioactive drugs that have been listed overseas within China. Priority review and approval will be given to the application for the marketing license of urgently needed radioactive drugs in clinical practice, and a long-term mechanism will be established for early intervention, continuous tracking, proactive service, and research review linkage. Communication and guidance throughout the entire process of research and development application will be strengthened. Strengthen communication and collaboration with the health regulatory authorities, include internationally listed and domestically unlisted radioactive drugs that are urgently needed in clinical practice in the encouraged generic drug catalog, and guide enterprises in research and development. In addition, optimize the evaluation mechanism to reflect the specificity of radioactive drugs. Improve the technical evaluation system for radioactive drugs and increase the number of reviewers with professional backgrounds. Reflect the characteristics of radioactive drugs in processes such as acceptance, technical evaluation, verification, and inspection. Research and improve the management methods and related requirements for precursors/ligands, nuclides, generators, cold kits, etc. Priority will be given to communication and exchange applications for radioactive drugs. In the acceptance process, formulate and improve relevant requirements for the acceptance and review of radioactive drugs, and strengthen guidance on application. Establish a dedicated channel for radioactive drugs during the review process, and provide a separate review sequence. Encourage overseas produced radioactive drugs that have been listed domestically to be transferred to domestic production, and clarify the technical requirements for generic drug evaluation and application materials that meet the characteristics of radioactive drugs. Optimize the mechanism of radioactive drug registration inspection and verification, and improve work efficiency. The Opinion also requires strengthening the supervision of production and circulation links. Strictly approve the production and operation of radioactive drugs for enterprises, implement local regulatory responsibilities and the main responsibility of the marketing license holder, require the holder to have an appropriate quality management system, and ensure that the drug production process continues to comply with drug production quality management standards and drug registration management requirements, ensuring the quality and safety of radioactive drugs. (New News Agency)
Edit：Ying Ying Responsible editor：Jia Jia
Source：People.cn
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