Bill On Manufacturing Individual Gene Therapy Pharmaceuticals In Medical Organisations Without State Registration Submitted to The State Duma
On 16 October 2026, the Russian Government submitted to the State Duma bill No. 12837-9 (Bill) amending Federal Law No. 61-FZ dated 12 April 2010 "On Circulation of Medicines" (Law on Circulation of Medicines).
The Bill introduces a special circulation regime for individual gene therapy pharmaceuticals (IGTPs): a medical organisation will be able to manufacture such a pharmaceutical for a specific patient and use it on its own premises without registration, on the basis of an authorisation issued by the Russian Ministry of Health.