Introduction to registration of biomedical cell products
According to the definition of the Federal Law № 180, a biomedical cell product (BMСP) is:
1). Cell line (cell lines) and excipients
2). Cell line (cell lines), excipients and registered medicines and medical devices (See more about BMCP, cell line, BMCP types by link.
Normative documentation for this type of product is in active development, but the fundamental principles concerning the circulation of BMCP are already set out in the Federal Law № 180 “On Biomedical Cell Products”.
- BMCP Registration Procedure.
The main stages of BMCP registration in the Ministry of Health include:
- Submission of registration dossier to the Ministry of Healthcare
- Expertise of quality and documents (100 working days) + Ethical expertise (25 working days)
- Clinical trials
- Expertise of the BMCP effectiveness + Expertise of the ratio of expected benefit to the possible risk (25 working days)
- Composition of the registration dossier
The information on completeness of the registration dossier is already registered in this federal law. According to Article 9 p. 2 the registration dossier on BMCP is formed from the following documents:
- Application for State registration of BMCP
- Power of attorney for the applicant
- Specification for BMCP
- Normative documentation for BMСP
- Primary and secondary packaging projects for BMCP
- Report on the pre-clinical trials of BMCP
- Report on clinical trials (CT) of BMCP
- Manufacturing specification of BMCP
- Patient Information Sheet
- Information about insurance payments to patients involved in the CT of BMCP
- Report on the results of international multicenter CT of BMCP, some of which were held on the territory of the Russian Federation
- Copy of the license for the production of BMСP
- Instructions for use of BMCP
- Document confirming payment of government fees
- How much?
According to Chapter 25.3 of the Second Part of the Tax Code of the Russian Federation, government fees (from 01.04.2018) comprise:
- Expertise of BMCP quality (result – permission to conduct CT, ethical expertise) – 200 000 rubles.
- Expertise of the effectiveness of BMCKP and the ratio of expected benefit to the possible risk-50 000 rubles.
- Expertise of BMCP efficiency, for which international multicenter CT were held – 200 000 rubles.
- Issuance of a permit to conduct CT for BMCP – 5 000 rubles.
- Issuance of Registration Certificate (RC) for BMCP – 5 000 rubles.
- Issuance of a duplicate of RC for BMCP – 5 000 rubles.
- Confirmation of State registration – 50 000 rubles.
- Introduction of changes in the RC, requiring expertise – 75 000 rubles.
- Introduction of changes in the RU, not requiring expertise – 5 000 rubles.
- Issuance of a permit to conduct international multicenter CT of BMCP – 100 000 rubles.
- Issuance of a permit to conduct post approval CT of BMCP – 100 000 rubles.
Thus, the registration process has been outlined, but there are many details that will be discussed in the following articles.