In order to further strengthen the manufacturing management of radioactive pharmaceuticals and ensure their quality, safety and effectiveness, in accordance with the Drug Administration Law, Provisions for the Administration of Radioactive Pharmaceuticals and other laws and regulations, the relevant issues are hereby announced as follows on January 13, 2022: 

I. The test of three consecutive batches of labeled radioactive pharmaceuticals has been adjusted to be done after a manufacturer has obtained the Production License for radioactive pharmaceuticals, and may be carried out simultaneously in combination with the dynamic production batch for GMP conformity inspection. The sample testing should be undertaken by drug testing institutions that meet the Provisions for the Administration of Radioactive Pharmaceuticals.

II. For the filing of a medical institution for the preparation of positron radioactive pharmaceuticals, the test of three consecutive batches of samples of the variety to be manufactured and the review of the quality standard should be undertaken by drug testing institutions that meet the Provisions for the Administration of Radioactive Pharmaceuticals.

III. Marketing authorization holders and manufacturers of radioactive pharmaceuticals and medical institutions preparing positron radioactive pharmaceuticals should be equipped with quality control and inspection personnel with professional knowledge related to radioactive pharmaceuticals, and such personnel should receive trainings adapted to the requirements of the post and be qualified in the assessment before taking up the position.

IV. Marketing authorization holders and manufacturers of radioactive pharmaceuticals and medical institutions preparing positron radioactive pharmaceuticals should earnestly fulfill the principal responsibility for drug quality management and strictly carry out quality control and inspection throughout the whole process of manufacturing. Products can be sold and used only after passing the quality tests.

V. Drugs containing radionuclides with a short half-life may be inspected while being released from the factory. However, in case of identifying any drug with the quality failing to meet the national drug standards, the marketing authorization holder and the manufacturer should immediately stop the manufacturing and sale, notify end users to stop the use, and take corresponding risk control measures.

VI. The provincial drug regulatory departments should strengthen the in- and post-process supervision, further strengthen the supervision and inspection of the manufacturing process of radioactive pharmaceuticals, urge radioactive pharmaceutical manufacturers and medical institutions to fulfill the principal responsibility for the quality and safety of radioactive pharmaceuticals, and ensure that the whole process of radioactive pharmaceutical manufacturing continuously meets the legal requirements.

VII. This Announcement should take effect as of the date of issuance. In case of any discrepancy between the provisions previously issued by the drug regulatory department under the State Council and this Announcement, this Announcement shall prevail.