The Ministry of Health of the Russian Federation has developed requirements for off-label drugs. This is reported by TASS with reference to the draft government decree (published on the official portal of draft legal acts).
“To approve the attached requirements for a medicinal product registered in the Russian Federation, used other than in accordance with the indications (characteristics) of the product specified in the instructions, which is allowed for inclusion in the standards of pediatric medical care and clinical recommendations,” the document says.
The press service of the Ministry of Health explained the following to the media:
“In accordance with the proposed amendments, a drug can be included in standards and clinical recommendations if two requirements are met, namely, if the effectiveness and safety of the drug are confirmed by clinical trials and/or research data published in indexed international academic journals.”
As the ministry recalled, off-label drug use becomes necessary in cases with severe, chronic, life-threatening, or disabling pathologies, when it is especially important to administer the drug promptly.
