According to the official website of the State Food and drug administration, in order to further strengthen the production and management of radioactive drugs and ensure the quality, safety and effectiveness of radioactive drugs, the State Food and Drug Administration recently issued the notice on matters related to further strengthening the management of radioactive drugs (hereinafter referred to as the notice). According to the circular, drugs containing short half-life radionuclides can leave the factory while being inspected. However, if it is found that the quality does not meet the national drug standards, the drug marketing license holder and the drug production enterprise shall immediately stop production and sales, notify the user to stop use, and take corresponding risk control measures. In addition, the inspection of three consecutive batches of samples of immediately labeled radioactive drugs shall be carried out after the manufacturer obtains the radioactive drug production license, which can be carried out simultaneously in combination with the dynamic production batches of compliance inspection of drug production quality management specifications. The sample inspection shall be undertaken by the drug inspection institution that meets the relevant provisions of the measures for the administration of radioactive drugs. When a medical institution prepares positron radioactive drugs for filing, the inspection of three consecutive batches of samples and the review of quality standards of the varieties to be produced shall be undertaken by the drug inspection institution that meets the relevant provisions of the measures for the administration of radioactive drugs. The holder of the marketing license of radioactive drugs, the manufacturer of radioactive drugs and the medical institution preparing positron radioactive drugs shall be equipped with quality control and inspection personnel with corresponding professional knowledge of radioactive drugs. The relevant personnel shall receive training appropriate to the job requirements and pass the examination before taking up the post. The holders of drug marketing licenses, drug manufacturing enterprises and medical institutions preparing positron radioactive drugs shall earnestly implement the main responsibility for drug quality management and strictly implement quality control and inspection in the whole process of production. Only qualified products can be sold or used. The circular requires that all provincial drug regulatory departments should strengthen the supervision during and after the event, further strengthen the supervision and inspection of the production process of radioactive drugs, urge radioactive drug production enterprises and medical institutions to implement the main responsibility for the quality and safety of radioactive drugs, and ensure that the whole process of drug production continues to meet the legal requirements. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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