BMCP in Russia – changes in the legislation.

Currently, the State Duma is considering a draft law on amendments to the Federal Law “On the Circulation of Medicines” and the Federal Law “On Biomedical Cell Products”. As part of the changes, it is proposed to simplify the circulation of BMCP, as well as to correct the definition of BMCP.

  1. Which products will be considered as biomedical cell products?

According to the current legislation BMCP is a complex consisting of a cell line (cell lines) and excipients or a cell line (cell lines) and excipients in combination with state-registered medicinal products for medical use (hereinafter referred to as medicinal products), and (or) pharmaceutical substances included to the state register of medicines, and (or) medical devices;

If changes are approved, this definition will be supplemented with a clarification on what does not apply to BMCP, namely: transplantation objects, as well as medicines (including high-tech drugs subject to registration in accordance with the requirements of the EAEU and / or Federal Law No. 61 “On the Circulation of Medicines”).

At the same time, the draft law expands the concept of BMCP, extending it also to products containing cells that have not undergone cultivation and (or) modification.

  1. Which BMCP do not require registration in Russia?

It is also planned to amend Article 8 on state registration of BMCPs and supplement it with information about BMCPs that are not subject to state registration. These include BMCPs, “intended for the execution of individual medical prescriptions of BMCPs, specially produced for an individual patient directly in the medical organization in which BMCP is used”

At the same time, the Government of the Russian Federation reserves the right to establish the procedure for the circulation of such BMCP, including the procedure for issuing a permit for its production and use.

  1. What other changes are planned?

The draft of the law also excludes the requirement for accreditation of medical organizations for the right to conduct clinical trials of BMCP as unclaimed and redundant.