The first clinical trial permission for biomedical cell product has been granted.
Clinical Study Part for BMCP was last updated on our website in 2018. This is because no special events have occurred since the legislation was drafted. 3 years later, in March 2021, the procedure started working and the first BMCP permission for clinical trial was issued to GENERUM.
Biotechnology company Generium has received approval to conduct a Phase III clinical trial for a product designed to repair knee cartilage defects. It is worth noting that a similar BMPC has already been approved by the European Medical Agency (EMA) and the UK National Health Committee on the basis of effectiveness and safety data. With its use, more than 11,000 patients in 150 clinics have been treated in the European Union over the past few years.
The clinical trial will be conducted in the following facilities:
- M. Sechenov First Moscow State Medical University (Sechenov University)
- Nasonova Research Institute of Rheumatology
- Federal Center for Traumatology, Orthopedics and Endoprosthetics in Smolensk
- Academician Ilizarov National Medical Research Center for Traumatology and Orthopaedics in Kurgan.
In addition to Generium, at least one company planned to launch the BMCP study and was ready to organize the expertise of samples at the production site. However, BMCP production is localized in the United States, and due to the outbreak of the Covid-19 pandemic, the expertise organization was cancelled.
Interestingly, in parallel with the first practical successes in preparing the BMCP to enter the Russian market, the EAEU regulatory framework is developing. According to Decision 78, BMPC refers to medicines and their circulation is accordingly governed by the same laws.
Whereas from January 1, 2021, it is not possible to register medicines in accordance with national requirements (only in accordance with EAEU), it is now a question for manufacturers how it is necessary register the BMCP.
We may soon come to legislation harmonization in which the logical solution would be to cancel Biomedical Cell Products Act No. 180 at all, but precedent with Generum could make this refusal difficult.