Biomedical Cell Product
| Main information about biomedical cell product (BMCP):
1 – Introduction – below on this page
2 – Formation of the Biomedical Cell Product name in the international practice (in by link )
3 – BMCP regulation – all information in one place
4 – International experience in the regulation of circulation of biomedical cell products – main information
5 – Registration process for BMCP in Russian Federation:
- introduction (main information about approval procedure – In English and in Russian)
- preclinical trials BMCP
- clinical trials
6 – Biomedical cell product circulation control:
7 – Organization of BMCP Storage – about cryorepository
8 – Labeling of BMCP
9 – Production of biomedical cell product
10 – Mesenchymal stromal cells as main component of biomedical cell product
11 – Biological material for the production of BMСP
12 – Permission for samples import (for biomedical cell products)
13 – Introduction of changes in the registration dossier for biomedical cell products
14 – Biomedical cell products quality indicators
15 – Examination of BMCP
16 – BMCP — problems and prospects of development in Russia (after IPhEB Russia 2019)
17 – Updates in licensing process – april 2019
18 – Biomedical cell product approval experience in USA and Europe
On 1 January 2017, the federal Law on Biomedical Cell Products (BMCP) came into force, regulating relations arising at all stages of the BMCP life cycle, including the registration of this type of product on the territory of the Russian Federation.
- What is BMCP?
According to the Federal Law No 180, the Biomedical Cell Product includes the following complexes:
1). Cell line (cell lines) and excipients
2). Cell line (cell lines), excipients and registered medicines and medical devices.
Cell line is the key component of a BMCP. According to the same Law, a cell line is a standartized cell population of one type with a reproducible cell composition which is obtained by removing the biological material from the body with the subsequent cell cultivation out of the body.
An example of BMCP is the Dermal Equivalent which is represented as epidermal cells in fibrinous or collagenous gel. This BMCP is used to restore skin cover after burns, trophic sores and other skin injuries.
Dendric cell vaccines obtained from monuclear blood cells are also BMCP. Their use is promising in the treatment of oncology disease.
- Types of BMCP.
When registering BMCP, it is important to specify its type in a document named specification, which is created after the preclinical trials. All BMCP can be divided into three types:
- An autologous BMCP: The human biological material is isolated, then cells are cultivated on the nutrient medium and used for the same person.
- An allogenic BMCP: The human biological material is isolated, then cells are cultivated on the nutrient medium and used for other people.
- A combined BMCP: Biological material is isolated from different people then cultivated and used for the one of the people.
- Registration of BMCP and its post-registration control.
Biomedical cell products are registered by the the Ministry of Health of the Russian Federation. The registration period is 150 working days and does not include clinical trials. The registration certificate is issued for 5 years and is extended every 5 years.
The subjects to the registration:
- BMCP put into civil circulation in the Russian Federation for the first time
- Previously registered BMCP, in case of changing of its type (an autologous, allogenic, combined), its qualitative and/or quantitative composition, the biological or other characteristics of the cell line and BMCP.
Once registered in the Ministry, the BMCP can be manufactured, disposed, used, stored, transported, imported in Russia and exported from Russia.
State supervision of BMCP circulation is carried out by the Roszdravnadzor. The powers of the Roszdravnadzor in respect of BMCP also include:
- Selective quality control of BMCP
- Making decisions about the suspension of BMCP application, withdrawal of falsified or poor-quality BMCP from circulation, disposal of falsified or poor-quality BMCP.
- Safety monitoring of BMCP
Thus, the Federal Law No 180 “On biomedical cell products” shows that BMCP is the new kind of product and has its own special aspects in circulation and registration.
Information from Roszdravnadzor website – below.
Information in Russian – by link (Биомедицинский клеточный продукт).
| Official information from Roszdravnadzor website
A biomedical cell product (BCP) is defined by the Law as a complex consisting of cell line(s) and excipients or cell line(s) and excipients in combination with the registered medicinal products for medical use (‘medicines’) and/or medical devices.
Biomedical cell products can be produced, sold, used, stored, transported, imported in and exported from the Russian Federation only after the state registration in the Ministry of Health of the Russian Federation.
According to the Statute on Federal Service for Surveillance in Healthcare (Roszdravandzor), approved by RF Government Decree dated 30.04.2004 № 323 (as amended on 31.01.2017) the powers of Roszdravnadzor in the context of BCP includes:
– state control over activities in the area of BCP circulation;
– random quality control of BCP;
– making decisions about the suspension of BCP application, withdrawal of falsified or poor-quality BCP from circulation, disposal of falsified or poor-quality BCP.
– safety monitoring of BCP.
Resource: official Roszdravnadzor website (in Russian) – http://www.roszdravnadzor.ru/biomedical
©Beawire – Oct 2018 with changes from June 2019.