Under the New year 2018 on the web site of Roszdravnadzor appeared an Order to approve the form of registration certificate (RC) for Biomedical Cell Products (BMCP) (Order of the Ministry of Health of Russia № 567n). According to this Order, RC for BMCP is issued on a special form, which should contain the following information:
- Number of the registration certificate
- Name of Biomedical Cell Product
- Trade name of BMCP (if available)
- Name of the holder of the registration certificate for BMCP
- Name and address of the manufacturer of BMCP
- Address of the factory sites for biomedical cell production
- Date of State registration of BMCP
- Validity of RU for BMCP
- Date of amendments to the documents contained in the registration dossier for the registered BMCP
- Type of biomedical cell product (autologous, allogenous, combined – find details by link https://beawire.com/biomedical-cell-products/)
- Intended use of BMCP in accordance with its instruction for use (indications)
- Characteristics of the cell line (cell lines) used in the production of BMCP
- Requisites of normative documentation for BMСP
At first glance, the list seems quite simple, but almost every item hides a lot of pitfalls and problems in regulation.
For example, paragraph 2 may already cause some difficulties in the formatio of the registration dossier. There are certain rules for forming a name of drugs and medical devices.
For medicinal products, there is such a term as an international generic name (INN) that reflects the name of the active substance/pharmaceutical substance recommended by WHO.
The name of the medical device should contain a sign that the product is intended for medical use and has a descriptive character (fetal monitor, medicinal cotton wool)
In the case of BMCP, in the USA in 2005 the Working Group on Cell Therapy USAN and CBER FDA developed nomenclature scheme of the name which is applied to all products of cellular therapy, except for the minimally processed hematopoietic cells, combined products and preventive vaccines.
The formula under which the name of this type of products is built includes the following elements:
- Prefix (assigned by the manufacturer to give uniqueness to the product name)
- Infix 1 (to indicate the type of processing, if applicable). For example, -gen- -genetic modification)
- Infix 2 (to identify the type of primary cells) For example, -end- endothelial cells)
- Suffix -cel (for the name of all products of cellular therapy, with some exception-see the scientific article)
- Stem-Qualifier (denotes the type of BMKP: T = Autologous, L = Allogenic, x = Xenogenic
For example, in the United States there are the following registered BMCP:
- Carticel, which is a autologous cartilaginous cells used for regeneratation of articular cartilage;
- Azficel-T is a drug of autologous fibroblasts, widely used in the field of aesthetic medicine to reduce the number and severity of wrinkles (see the article SPRS-therapy)
In Russian legislation, the issues of the system of naming BMCP, registration of such products and their introduction to the market are still under development. In official sources there is no information about the biomedical cell products registered on Russian territory.
Ministry of Health of the Russian Federation developed the procedure of maintaining the State Register of BMCP (Order of Ministry of Health of Russia dated 31.05.2017 № 281 N) However, the register is absent on the Ministry of Health web site.
In connection with the abovementioned, it is possible to conclude that the process of introduction of BMCP to the Russian market has not started yet, but the Ministry of Health of Russian Federation and the Russian government are actively developing normative acts concerning the circulation of BMCP.
- Олефир Ю.В., Меркулов В.А., Романов Б.К., Дудченко В.В., Попов П.И., Бутнару Д.В., Мельникова Е.В., Меркулова О.В., Чапленко А.А., Яворский А.Н. Номенклатура биомедицинских клеточных продуктов // Ремедиум. №3. –nomenklatura-biomeditsinskih-kletochnyh-produktov