International experience in the regulation of circulation of biomedical cell products (BMCP)
Nowadays Ministry of Health of Russia and Government of the Russian Federation actively develop regulatory documents, clarifying the process of circulation (including registration) of biomedical cell products.
Thus, since 2018 on the web site of Roszdravnadzor there have been published 4 new Orders, regulating:
- The Rules of transportation of biological material, cells for the preparation of cell lines and cell lines themselves (Order of Ministry of Health dated 28.08.2017 №564n)
- The procedure of marking of the primary and secondary packaging for the autologous BMCP and combined BMCP (Order of Ministry of Health dated 13.10.2017 №800n)
- Safety monitoring, conducted by the holder of the registration certificate (RC)
- Form of the statement for the BMCP document changing process (Order of Ministry of Health dated 20.10.2017 №837n)
During 2017 Ministry of Health and Government of Russian Federation published in total 16 regulatory documents about the circulation of BMCP.
Other countries are also actively involved in the development of regulatory base in relation to BMCP because medicine is need of these products.
EU uses the term “advanced therapeutic medicinal products – ATMPs” which includes three product categories:
- Therapeutic products, based on somatic cells
- Gene therapeutic products
- Tissue engineered products
The basis for the regulation of BMCP is REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF). There was also developed GMP standard in relation to ATMP.
The key elements of ATMP regulation include:
- Centralized registration procedure
- Creation of new expert committee which is aimed at the evaluation of ATMP, development of recommendations about the clinical trial design and confirmation of preclinical trials.
- Individual technical requirements, requirements to the risk management and its monitoring.
Food and Drug Administration of FDA is responsible for the safety, quality and effectiveness evaluation of Human Cells, Tissues, and Cellular and Tissue-based Products – HCT/Ps indicated for the medical purposes. (Link https://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/RegulationofTissues/ucm150485.htm)
According to the US regulation cell products can be considered as preparations based on human cells and tissues or biological products.
In case, if:
- Cell and tissue processing doesn’t change the initial characteristics of product
- Product is used in accordance with the instruction for use
- Product is not combined with other materials (except water, soline solutions, preservatives)
products are considered to be preparations based on human cell and tissue products and are regulated by the section 361 PHS Act (Law “About medical services”). Otherwise, they are regulated by 351 PHS Act or Food, Drug and Cosmetics Act) and are considered as drugs or biological products and are subjects of the traditional biologic license application. Their produсtion must meet the requirements of GMP.
In conclusion, three above mentioned examples allow to conclude that formation of regulatory base has different approaches and criteria of inclution to the group of BMCP. Thus, in the USA the key moment in the regulation of circulation of BMCP is its modification. At the same time in Russia both native and modified BMCP are regulated by the same Federal Law № 180 “About biomedical cell products”.
** Russian version – Международный опыт регулирования в области обращения биомедицинских клеточных продуктов, вы также можете воспользоваться переключением языка с правой стороны страницы
- Пятигорская Н.В., Тулина М.А., Аладышева Ж.И., Береговых В.В. Международные подходы к регулированию препаратов клеточной терапии // Вестник РАМН. 2013. №8. C. 5 – 151-88-1-PB (1) – in Russian