Changes allowing the use of off-label drugs during clinical testing will be made to the provision on the organization of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation and medical care as part of clinical testing. The draft order of the Ministry of Health of Russia published on the portal regulation.gov.ru.
Amendments will be made to Ministry Order No. 433n of 10.07.2015. “Within the framework of clinical testing, the use of drugs and medical devices registered in accordance with the established procedure in the Russian Federation is allowed for indications not indicated in the instructions for their medical use and (or) operating guidelines, by decision of the medical council or the medical commission of the medical organization in which clinical testing is carried out,” the draft order says.
Since 2015, a mechanism of clinical testing has been operating in Russia – the practical application of the methods of diagnosis, rehabilitation, prevention and treatment created and not previously used by medical organizations in the provision of medical care to confirm their effectiveness.
In 2019, the Russian government introduced a differentiated approach to admit new high-tech to the implementation of clinical testing protocols, since some of the previously existing criteria could be met only after several years of work of scientific centers.