The government has approved requirements for the off-label use of drugs for children. Previously, patient communities have repeatedly asked to speed up the adoption of the document.
The government has issued a decree with approved requirements for the off-label use of drugs for children. The text of the government resolution is available on MV.
According to the document, the inclusion of an off-label drug in the standards of medical care for children and clinical recommendations (CR) is allowed if it meets a number of conditions. The effectiveness and safety of the drug must be confirmed by scientific research data and (or) descriptions of clinical cases published in the Russian Science Citation Index database, and (or) in the Scopus or Web of Science databases, in relation to each deviations from the instructions. This includes indications for use, and (or) dosage regimen and method of administration, and (or) interaction with other drugs.
Secondly, an indication of the effectiveness and safety of the drug must be confirmed by its inclusion in the recommendations adopted by international professional organizations.
The document comes into force on September 1, 2024. It was initially assumed that the new rules could come into force from September 2023, then the deadline was postponed to March 1, 2024. Then the All-Russian Patients’ Union declared that any delays for such a document were inadmissible. The organization argued that clinics would be able to start using off-label drugs in minors with a delay of six months, given the length of time it takes to develop and approve clinical recommendations and approve standards of medical care, MV reported.