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2024/07/09 16:30:04

Radiopharmaceuticals (Russian market)

Content

2023

More than 800 thousand examinations of patients with the use of radiopharmaceuticals are carried out annually in Russia

More than 800 thousand studies and medical procedures using radiopharmaceuticals are carried out annually in Russia. This was announced on June 21, 2024 by the Minister of Health of the Russian Federation Mikhail Murashko.

Etti research is carried out within the framework of the federal project "Fight against cancer," which has been implemented for five years. Mikhail Murashko noted that all procedures are fully covered by insurance medicine and are free for Russian citizens.

More than 800 thousand patient examinations using radiopharmaceuticals are carried out annually in Russia

The Minister also stressed that to accelerate the introduction of new drugs in the field of nuclear medicine, a certain regulator has been changed. This allows for faster delivery of innovative developments to patients, improving the quality and availability of care.

According to Mikhail Murashko, the use of radiopharmaceuticals significantly expands the possibilities for the diagnosis and treatment of various diseases, primarily cancer. These drugs allow high-precision research that helps identify diseases in the early stages and prescribe effective treatment.

The use of radiopharmaceuticals in medical practice contributes to a significant reduction in mortality from cancer. According to the Ministry of Health of the Russian Federation, the annual increase in the number of procedures performed indicates growing confidence in nuclear medicine from doctors and patients. The development of nuclear medicine is one of the priorities of the Russian health policy. In recent years, investment in this area has increased significantly, which has made it possible to modernize equipment and introduce advanced technologies.

According to Murashko, the Ministry of Health also actively cooperates with international organizations and specialists in the field of nuclear medicine.[1]

Russian oncologists cured the cancer of the last stage with the help of a new radiopharmaceutical

In September 2023, researchers from the Tomsk Research Institute of Oncology, TNIMC RAS presented the results of the successful treatment of stage four prostate cancer. Experts used the radiotherapy drug Lutetium-117 PSMA. Read more here.

Discovery of the first GMP laboratory of cellular technologies in Russia for the treatment of cancer

In January 2023, the Kaluga Region opened the first GMP laboratory of cellular technologies in Russia. It was launched at the A.F. Tsyba Medical Radiological Scientific Center. Read more here.

2022: A medical cabinet for the production of radiopharmaceuticals has been created in Russia

N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of Russia together with the Russian company Medkar created a Russian analogue of the module ("medical cabinet") for the production of radiopharmaceuticals (used for radionuclide diagnostics and treatment of various diseases using nuclear medicine methods). This was reported in the press service of the National Medical Research Center in November 2022. Read more here.

2021: Ministry of Industry and Trade allocates 125 million rubles for the development of a radiopharmaceutical

As it became known in early May 2021, the Ministry of Industry and Trade approved the application of the Federal State Budgetary Institution "Russian Scientific Center for Radiology and Surgical Technologies named after A.M. Granova" for the development of a drug for radionuclide therapy. 125 million rubles will be allocated for this project. Read more here.

2020: The Russian Ministry of Health approved an order of production of radiopharmaceuticals in medical institutions

In December 2020, the Ministry of Justice of the Russian Federation registered an order of the Ministry of Health, which approves a new procedure for the manufacture of radiopharmaceutical drugs in medical institutions. The document specifies the requirements for premises, equipment and personnel, quality control taking into account radiation safety standards, the requirements of sanitary and epidemiological rules and hygienic standards established by law.

The Ministry of Health of Russia approved the procedure for the manufacture of radiopharmaceuticals in medical institutions

In accordance with the requirements of the Ministry of Health, the medical organization should develop requirements for the system of documentation for the manufacture of radiopharmaceutical drugs (RLS), control and quality assurance, taking into account the requirements of the relevant pharmacopoeial articles with a detailed and consistent description of the implementation of all production operations, including:

  • receipt, identification, marking, processing, sampling, use, storage and destruction of WLD;
  • maintenance and inspection of environmental monitoring instruments and equipment;
  • preparation of initial substances;
  • Maintain records, reports, and store them
  • maintenance of instruments, equipment and premises in which RLP is manufactured;
  • reception, placement, storage, description, identification of raw materials and raw materials;
  • maintenance of records related to the manufacture and quality control of manufactured WLDs.

The FPM will be made at the written request of a medical organization employee as prescribed by a doctor. At the same time, the employee of the medical organization, when issuing a radiopharmaceutical product, is obliged to check the packaging, details of the application of the medical institution and the labeling of the drug.

The order will enter into force on January 1, 2021 and will be valid until January 1, 2027, the document says. The previous procedure for the manufacture of FPM was approved by the Ministry of Health in 2015.[2]

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