Clinical investigations (CIs) of biomedical cell products (Biomedical cell products) are an integral part of the registration process. CIs are conducted on the basis of the permission to conduct CI of BMCP, issued on the basis of the results of the first stage of the expertise in the expert center of the Ministry of Health of the Russian Federation.

1. Who organizes?

According to the Federal Law 180, the following organizations can organize clinical investigations:

– An organization that has rights for BMCP or its authorized legal entity

– Educational organization of higher education

– Scientific organization

2. Purposes of clinical investigations

– Establishment of safety and (or) portability profile and side effects of BMCP

– Establishment of safety, efficacy and optimal dosages of BMCP

– Identification of the specifics of the interaction of BMCP with medicines, medical devices, food products and other BMCP

– Study of the possibility of expanding the indications of the BMCP

The clinical research plan includes studies of pharmacodynamics, pharmacokinetics, dosages, and randomized clinical trials.

Pharmacodynamics is a field of science devoted to the study of the main and side effects of drugs and BMCP and the mechanisms of their development. Roughly speaking, pharmacodynamics studies the effect of the product on the body.

Pharmacokinetics is a field of science devoted to the study of absorption, distribution, metabolism and excretion of the drug, i.e. the way the body reacts to the product.

3. Who conducts?

– one or more accredited medical organizations.

A medical organization can be accredited for investigations to achieve one, several or all of the goals.

The purpose of accreditation is the recognition of the possibility of a medical organization to carry out CI of BMCP on the profile of the disease for which the BMCP is intended.

The list of accredited medical organizations can be viewed on the website of the State Register of Medicines.

4. What is required?

– Contract on the conduct of CI of BMCP

– Specification on BMCSP (on the results of preclinical trials)

– Researcher’s brochure

– The CI protocol developed by the organization that organizes the CI of BMCP.

At the end of the CI, a report on the results of CI is prepared. It is drawn up in written form by the organization conducting the organization of the CI of BMCP, on the basis of the conclusions of the medical organizations that conducted the study.

References:

1. ФЗ № 180 «О биомедицинских клеточных продуктах»
2. Постановление Правительства РФ от 25.08.2017 N 1015 «Об утверждении Правил аккредитации медицинских организаций на право проведения клинических исследований биомедицинских клеточных продуктов»
3. Приказ Минздрава России от 22.09.2017 N 669н (ред. от 25.12.2017) “Об утверждении Правил надлежащей клинической практики биомедицинских клеточных продуктов”