The Cabinet proposed to simplify the creation of individual medicines for the patient
The State Duma introduced a bill on a special regime for high-tech drugs. It will allow the production of individual drugs without state registration, which will accelerate the introduction of personalized cancer vaccines
The State Duma introduced a bill that provides for the creation of a special legal regime for high-tech drugs manufactured for individual medical purposes. These may include domestic drugs used in the treatment of cancer.
The document provides for amendments to the law “On the circulation of medicines”. It introduces three new high-tech drugs:
individual biotechnological: from made specifically for a specific patient, using data from genetic studies. individual gene therapy: correct the work of genes (correction, replacement, addition or deletion), and are created for a specific person. tissue engineered: help repair or replace damaged body tissue.
In addition, the bill provides that these drugs can be produced, sold and used without state registration. The exception is tissue engineering.
This will legalize the production of drugs that are created directly for one patient.
As noted by “Parliamentary newspaper”, under the type of individualized biomedical preparations falls personalized vaccine against cancer. According to Denis Logunov, director of the Gamalea Center, the creation of a personalized antitumor mRNA vaccine takes about two to three months.
In April, the first patient received a personalized anti-tumor mRNA vaccine called Neonkovak to treat melanoma. The project was created jointly with N.F. Gamalei NICEM. The vaccine is made individually and must “tune” the immune system to recognize and destroy tumor cells, including microscopic foci. Until the end of 2026, the vaccine was planned to be used for at least 20 more patients.
On the eve of the Ministry of Health of Russia registered the drug "Nimolantsim", which is designed to treat tumors of the esophagus, head and neck, as well as certain types of malignant brain tumors.
According to the WHO, cancer remains the second most common cause of death in the world after cardiovascular disease. About 20.6 million new cancer cases and nearly 10 million deaths are reported worldwide each year.
