Biomedical Cell Products

2023

Ministry of Health for the first time registered a Russian biomedical cell product

In mid-December 2023, the Ministry of Health of the Russian Federation announced the registration of the first biomedical cell product. We are talking about a drug called Isitens, which was developed by Generium. Read more here.

Sechenov University has developed a unique cellular voice restoration technology

Scientists at the Sechenov First Moscow State Medical University have developed a laryngeal implant that helped to cope with a defect in the vocal folds and restore them to a natural, natural state. The press service of the university spoke about the creation of a unique cellular technology for restoring voice in early August 2023. Read more here.

NMITs named after V.I. Kulakova began construction of the production of cell drugs for 1.5 billion rubles

On July 25, 2023, it became known that the National Medical Research Center (NMIC) for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakova signed a contract for design and survey work for the construction of cell drug production. Approximately 50 million rubles will be allocated for these purposes, while the total cost of the project is 1.5 billion rubles. Read more here.

The first tissue engineering product in Russia is presented

In mid-July 2023, the Generium company announced the creation of the first fabric engineering product in Russia. We are talking about a technology for the restoration of cartilage tissue based on the use of an autologous cell product - cells of the patient's own cartilage. Read more here.

Putin instructed to develop a program for the development of biomedical technologies

In April 2023, the President Russia Vladimir Putin instructed to consider the implementation and financing of a program for the development of biomedical technologies, taking into account the results of scientific research in the field of demography and increasing life expectancy. The order Government of the Russian Federation must be fulfilled by October 15, 2023.

Submit proposals for the development, definition of mechanisms for the implementation and sources of financing of a comprehensive program for the development of biomedical technologies, providing for the use of the results of scientific research to solve problems in the field of demography, including an increase in life expectancy, health promotion and an increase in the period of active work capacity of the population of the Russian Federation in different age groups, the Kremlin website says.

Russian President Vladimir Putin

The government was also instructed to form a unified biotechnological circuit on the basis of the Sirius Scientific and Technological University for the introduction of production technologies for the most popular classes of biotechnological medicines. The Research Institute of Systems Biology and Medicine of Rospotrebnadzor and other organizations will be involved in this work.

In addition, Putin instructed to optimize expert councils operating under federal authorities and state corporations. Representatives of high-tech public and private companies must be involved in their work. The task is to form a unified system of expertise of scientific and technical programs and projects financed from the budget.

The list of presidential instructions was published following a meeting of the Council on Science and Education, which took place on February 8, 2023.^[1]

Mishustin simplified licensing of the production of biomedical cell products

In February 2023, Prime Minister Mikhail Mishustin signed a decree on amending the regulation on licensing activities for the production of biomedical cell products (BMKP). The main innovations are as follows:

• an application for verification of information in the application of the applicant for a license for the production of biomedical cell products can be submitted through the State Public services portal using an electronic signature;
• only details of documents can be specified in the application without providing their copies;
• the terms of assessment of compliance of the license applicant or licensee with the established requirements are also reduced to 5 working days. If the applicant conducts activities in the territory of a closed administrative-territorial entity, - up to 20 days.
• it became possible to assess the compliance of the license applicant remotely - using audio or video communication, photo and (or) video filming.
• the procedure for assessment is regulated. In addition, conditions are established for involving experts in such an assessment.

In February 2023, Prime Minister Mikhail Mishustin signed a decree on amending the regulation on licensing activities for the production of biomedical cell products

The document will enter into force on September 1, 2023.

The initiative to simplify the verification of information in the application of the applicant for a license for the production of BMKP Ministry of Health was made in October 2022. Then the department explained that for four years of the provision on licensing, only five applications for public services were submitted and one check of license applicants was carried out. By February 2023, JSC "" has the right to issue BMKP in the country. Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology A.I. Burnazyan Federal Medical Biophysical Center GeneriumRESOLUTION On Amendments to the Regulation on Licensing of Activities for the Production of Biometric Cell Products

2022: Rostec began to create a Center for High Biomedical Technologies for projects to replace lost organs and grow living tissues

Rostec began to create a Center for High Biomedical Technologies (CVBMT) in Surgut for projects to replace lost organs and grow living tissues. The press service of the state corporation announced this on September 26, 2022. Read more here.

2020: Roszdravnadzor issued the first license in Russia for the production of biomedical cell products

On April 27, 2020, the Federal Service for Supervision in Healthcare (Roszdravnadzor) issued the first license for the production of biomedical cell products. Which pharmaceutical company received such permission is not specified.

As the Russian Information Agency explained to TASS in the press service of the Russian Ministry of Health, biomedical cell products (BMKP) are cultured human cells and are widely used in regenerative medicine. They can be autologous - derived from the patient, allogeneic - derived from the donor and combined.

The first license for the production of cultured human cells was issued in Russia

Such products are used in the therapy of diseases of the musculoskeletal system (for example, the restoration of damage to the cartilaginous surface of the joint), ophthalmology (corneal restoration), oncological and other diseases, which significantly reduces disability.   Allogeneic products are widely studied and used in the world for the treatment of systemic diseases such as gonarthrosis, cardiovascular diseases, diseases of the gastrointestinal tract, and severe life-threatening conditions, such as acute myocardial infarction or acute respiratory distress syndrome, which is one of the main complications in severe course. COVID-19

Regenerative medicine is one and the most rapidly developing areas of medicine and its main task is to replace and/or restore the function of the organ or tissue affected by the disease in cases where the body's own regenerative capabilities are not able to ensure the repair or healing of the defect. Regenerative medicine methods are aimed at the therapy of severe socially significant diseases with a high level of disability, as well as at filling therapeutic niches with high unmet needs. The turnover of BMKP is regulated by the Federal Law of June 23, 2016 No. 180-FZ "On Biomedical Cell Products," the Ministry of Health added^[2]

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