More than two years have passed since the coming into force of the Federal Law No. 180 “On biomedical cell products”, however, no production site has yet passed the licensing procedure and no drug did not set foot on the national registration trail. Meanwhile, the EAEU market is becoming increasingly accessible not only for medicines and medical devices, but also for biomedical cell products.

Within the framework of national regulation, biomedical cell products (BMCP) is a separate category of products, for which a whole set of legal and regulatory acts (LRAs) are developed. Only in the period from 2016-2019, more than 50 of them were accepted. At the same time abroad (in the EU, USA, Canada, South Korea, Japan, Singapore) BMCP is considered to be biological drugs.  In terms of the EAEU countries, the term BMCP exists only in the national legislation of Belarus, but it has a different meaning: “transplantation material obtained based on human cells, with the exception of embryonic, fetal and hematopoietic stem cells, genetically modified human cells.”

It is worth noting that in Russia BMCP is a complex consisting of cell line (cell lines) and excipients or cell line (cell lines) and auxiliary substances in combination with approved medicinal products for medical use (hereinafter – medicines), and/or pharmaceutical substances included in the state register of medicines, and (or) medical devices;

According to the Russian definition of BMCP it is clear that this type of products in the Russian Federation can have a much wider composition and their functional purpose is not limited to the transplantation.

In the normative legal framework of the EAEU the term BMCP is absent, but the EAEU Council Decision No. 78 introduces the concept of high-tech drugs. Note that in the case of the EAEU HTDs are also regulated by normative acts for medicines. The HTD group consists of two subgroups: genotherapeutic drugs and somatic cell-based drugs.

According to the nomenclature of Decision No. 78, a gene therapy medicinal product is “a biological drug which:

• contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;
• therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence

It is worth noting that this definition is a translation of the term given by the European Medicines Agency (EMA).

Genotherapeutic drugs do not include vaccines against infectious diseases.

A drug based on somatic cells is a biological drug:

• containing or consisting of cells or tissues which have been substantially manipulated in such a way that their biological characteristics, physiological functions or structural properties significant for clinical use have been modified; or consisting of cells or tissues that are not intended to be used to perform the same basic functions in recipient and donor.
• used in humans for the purpose of treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

It is interesting that licensing of production of BMCP (national registration) is carried out by the Federal service for supervision in the sphere of health (Roszdravnadzor), and for EAEU licensing Ministry of Industry and Trade (Ministry of Industry and Trade) is engaged in.

Thus, there are currently two separate regulatory systems for highly tech drugs. It is up to the manufacturer to choose the strategy for placing such drugs on the market.

References:

• Federal Law No. 180 “On biomedical cell products”
• Decision of the Council of the Eurasian Economic Commission of 03.11.2016 N 78 (ed. 30.01.2020) “On the Rules of Registration and Expertise of Medicines for Medical Use”
• Merkulov V.A., Melnikova E.V. Biomedical Cell Products or High-Tech Drugs? BIOpreparations. Prevention, Diagnosis, Treatment. 2019;19(2):94-98. (In Russ.) https://doi.org/10.30895/2221-996X-2019-19-2-94-98