The Federal Law of 03.08.2018 N 323-FZ “On amendments to separate legislative acts of the Russian Federation on the issue of circulation of biomedical cell products” is expected to enter into force soon. What questions can be clarified by this normative document regarding the circulation of BMCP?

First of all, this bill introduces the production of BMСP to the list of licensed activities. This means that, since the entry into force of this federal law, the federal law “On licensing of certain activities” will be applied to the BMCP.

According to this law, the license applicant will have to meet the following general requirements:

1. To have premises, buildings, technical equipment, etc. for performance of works and rendering of services constituting licensed type of activity.
2. To have staff with professional education and qualifications.
3. To have a system of required production control
4. To Comply with the requirements of legislative acts relating to the legal entity form of the company, the size of the authorized capital.

In addition, the Ministry of Health of the Russian Federation is preparing a resolution on the approval of the regulation on licensing the production of biomedical cell products. Accoring to this Regulation, the Federal Service for Health Supervision (Roszdravnadzor) will be licensing the production of BMCP. This regulation also defines a number of individual requirements for the applicant license, namely:

1. Availability of regulations, including the list of used cell lines, medicinal products, medical devices and excipients with indication of quantity of each of them, the data on the used equipment, the description of the technological process and methods of control at all stages of production of BMCP;
2. Presence of the authorized person of BMCP manufacturer which carries out confirmation that BMCP meets the requirements, established at their state registration, and confirmation that process of their production meets the requirements of good practice on work with BMCP ;
3. Adherence to the rules of good practice on work with biomedical cell products;
4. Compliance with the requirements of the Federal Law № 180 “on Biomedical Cell Products”

What does it mean for the registration procedure of BMCP?

As for the registration process, the license for the production of BMCP is one of the necessary documents of the registration dossier. If in Russia regulation in the field of licensing of production of BMCP is at the stage of formation, then abroad are widely known GMP certificates (Good Manufacturing Practice) and GTP (Good Tissue Practice), necessary for the production of BMCP and the provision of which (or their analogues) is necessary when registering BMCP of foreign production.

References:

1. FZ № 180 “On Biomedical Cell Products”
2. Draft resolution “On approval of the regulation on licensing of the production of biomedical Cell Products”
3. Draft of the Federal Loaw dated 03.08.2018 N 323-FZ “On amendments to separate legislative acts of the Russian Federation on the issue of treatment of biomedical cellular products”
4. https://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/tissue/ucm285223.pdf