The State Food and Drug Administration Announces Matters Concerning Strengthening the Administration of Radioactive Drugs

The inspection of three consecutive batches of samples of instant-labeled radiopharmaceuticals is adjusted to be carried out after the manufacturer has obtained the radiopharmaceutical production license; drugs containing radionuclides with short half-life can be inspected while leaving the factory.
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On January 14, the State Food and Drug Administration issued "On Further Strengthening Announcement on Matters Concerning the Administration of Radiopharmaceuticals" to strengthen the production management of radiopharmaceuticals and ensure the quality and safety of radiopharmaceuticals
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The relevant requirements will be implemented from the date of issuance of the notice
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The notice pointed out that the inspection of three consecutive batches of samples of instant-labeled radiopharmaceuticals is adjusted to be carried out after the manufacturer has obtained the radiopharmaceutical production license, and can be carried out simultaneously with the dynamic production batches of the compliance inspection of the drug production quality management standard
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The sample inspection shall be undertaken by the drug inspection agency that complies with the relevant provisions of the "Administrative Measures for Radioactive Drugs"
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When a medical institution prepares a positron-based radioactive drug for record, the inspection of three consecutive batches of samples of the product to be produced and the review of the quality standard shall be undertaken by the drug inspection agency that complies with the relevant provisions of the "Administrative Measures for Radioactive Drugs"
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Radioactive drug marketing license holders, radioactive drug manufacturers, and medical institutions that prepare positron-based radiopharmaceuticals shall be equipped with quality control and inspection personnel with corresponding professional knowledge of radioactive drugs, and relevant personnel shall receive training and assessments that are commensurate with job requirements Qualified to work
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The notice clarifies that drug marketing license holders, drug manufacturers, and medical institutions that prepare positron-based radioactive drugs should earnestly implement the main responsibility for drug quality management, and strictly implement quality control and inspection throughout the production process
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Only products that pass the quality inspection can be sold or used
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Drugs containing radionuclides with short half-lives can be tested while leaving the factory
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However, when it is found that the quality does not meet the national drug standards, the drug marketing license holder and drug manufacturer should immediately stop production and sales, notify the user to stop using it, and take corresponding risk control measures
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The circular requires that all provincial drug administrations should strengthen interim and ex post supervision, further strengthen the supervision and inspection of the production process of radiopharmaceuticals, urge radiopharmaceutical manufacturers and medical institutions to implement the main responsibility for the quality and safety of radiopharmaceuticals, and ensure that the entire process of drug production continues to comply with statutory regulations.
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