The Russian Ministry of Health proposed to strengthen the supervision of the production of radiopharmaceuticals The Russian Ministry of Health has prepared a draft decision that allows for an increase in the risk category for organizations that produce radiopharmaceuticals. The changes will allow Roszdravnadzor to carry out routine inspections of relevant facilities. According to the document, it is proposed to assign 37 risk points to the production of radiopharmaceuticals. The norm will affect medical organizations and industrial pharmacies that have the right to produce such drugs. According to the current criteria, more than 36 points are required to classify an activity as a high risk category. The project also clarifies the evaluation procedure for organizations operating at multiple addresses. In such cases, the risk score will be determined according to the address with the highest score. The need for changes is related to the potential consequences of violations in the production of radiopharmaceuticals containing radioactive isotopes. In particular, failure to maintain sterility may lead to infectious complications and additional radiation exposure to patients. Amendments are proposed to the Decree of the Government of the Russian Federation of June 29, 2021 No. 1049, which regulates the supervision of the federal state in the field of drug circulation. Read us in Max Telegram VK.