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calendary January 22, 2024

Rules of circulation of biomedical cell products manufactured for the particular patient

The Ministry of Health of the Russian Federation has developed a draft of government decree (GD) on the procedure of circulation of BMCP manufactured for a specific patient in a medical institution. If the draft is approved, the GD will enter into force on September 1, 2024 and will be valid until September 1, 2030.

According to the draft of GD, the production and use of individual BMCPs will be able to be carried out by medical organizations that have a special permission. To receive this permission, an organization must verify:

  • The presence of a medical license for the profile of the use of BMCP;
  • Licenses for the production of BMCP;
  • Availability of resuscitation or intensive care unit;

It follows from the draft resolution that ethical and biomedical examinations will have to be carried out for the production and use of BMCP.

The term for conducting an ethical review is no more than 22 working days from the date of receipt of the relevant referral from the Ministry of Health of Russia. The following documents will be required for the examination:

  1. Application for the production and use of BMCP;
  2. Specification;
  3. Draft of the normative document;
  4. Drafts of layouts of primary and secondary packaging;
  5. Report on the conducted preclinical study;
  6. Results of previous scientific studies of the clinical application of BMCP;
  7. Draft of the manufacturing specification;
  8. Patient Information Sheet.

In addition, the resolution lists the requirements for information that will need to be applied to the primary and secondary packaging, as well as the shipping container in which the BMCP is planned to be transported:

Primary packaging Secondary packaging

·        Name and trade name of BMCP

·        Name of medical organization-manufacturer

·        Type of product (autologous, allogeneic, combined)

·        Method and frequency of application

·        Patient's name and card number

·        All data from the primary packaging

·        Information about sterility

·        Information about the absence of infectious agents in it (mycoplasma, HIV1, HIV2, hepatitis B virus, hepatitis C virus, treponema pallidum, etc.)

·        Conditions of transportation

The Ministry of Health also proposes to add BMCP biomedical expertise to the list of services that are necessary and mandatory. The corresponding decree was also published on the legal portal.

References:
  1. https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=141329
  2. https://regulation.gov.ru/Regulation/Npa/PublicView?npaID=141319
  3. https://pharmvestnik.ru/content/news/Minzdrav-predlojil-poryadok-obrasheniya-BMKP-dlya-individualnyh-naznachenii.html?utm_source=main

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