The State Duma of the Russian Federation, at its the plenary session on Wednesday, December 22, adopted in the third, final reading a bill on the pediatric use of medicines that are not approved by authorized bodies for the specific indication (off-label drugs).
According to the bill, off-label drugs already included in clinical guidelines or standards of medical care will be allowed for pediatric use, subject to informed consent of the patient or their representative.
The bill also allows a teenager who has reached the age of 18 to continue treatment in the same children’s center until the age of 21. The list of diseases for the treatment of which off-label prescriptions are allowed will have to be approved by the government.
On December 21, it became known that the State Duma adopted in the second reading a bill on the treatment of children with off-label drugs.