New GMP requirements for cell medicines and gene therapy came into effect in the EAEU since October 28, 2026. The Eurasian Economic Union has separate Good Manufacturing Practice (GMP) requirements for high-tech medical products. The changes were approved by the decision of the Council of the Economic Committee of Eurasia dated September 9, 2026 No. 103. The GMP rules have been supplemented with a new Part IV, which regulates the production of registered and investigational high-tech drugs, including cell and gene therapy. At the same time, such drugs are not included in the scope of Appendix No. 2, which is dedicated to the production of biological drugs. The new requirements include: a risk-based approach. The manufacturers will be able to adjust quality control measures based on the characteristics of the drug, the source of the biological materials and the characteristics of the manufacturing process. However, compliance with GMP requirements remains mandatory. Traceability of cellular material. It must be ensured that cells and tissues can be traced from the donor to the finished product and its delivery to the patient. Certain traceability data must be kept for at least 30 years after the product's expiration date. Special invitation for the release of the episode. For drugs with a short shelf life, release is permitted until all quality control test results are received. There is a step-by-step approval of batches and procedures for responding to nonconformities discovered after release. Distributed production. Production can be organized at multiple sites located closer to patients. In this case, a central site must be designated within the territory of the EAEU, which ensures supervision of the production facilities and compliance with the established batch release procedures. Separate instructions are devoted to the production of drugs for clinical trials.

New GMP requirements for cell medicines and gene therapy came into effect in the EAEU since October 28, 2026. The Eurasian Economic Union has separate Good Manufacturing Practice (GMP) requirements for high-tech medical products. The changes were approved by the decision of the Council of the Economic Committee of Eurasia dated September 9, 2026 No. 103. The GMP rules have been supplemented with a new Part IV, which regulates the production of registered and investigational high-tech drugs, including cell and gene therapy. At the same time, such drugs are not included in the scope of Appendix No. 2, which is dedicated to the production of biological drugs. The new requirements include: a risk-based approach. The manufacturers will be able to adjust quality control measures based on the characteristics of the drug, the source of the biological materials and the characteristics of the manufacturing process. However, compliance with GMP requirements remains mandatory. Traceability of cellular material. It must be ensured that cells and tissues can be traced from the donor to the finished product and its delivery to the patient. Certain traceability data must be kept for at least 30 years after the product's expiration date. Special invitation for the release of the episode. For drugs with a short shelf life, release is permitted until all quality control test results are received. There is a step-by-step approval of batches and procedures for responding to nonconformities discovered after release. Distributed production. Production can be organized at multiple sites located closer to patients. In this case, a central site must be designated within the territory of the EAEU, which ensures supervision of the production facilities and compliance with the established batch release procedures. Separate instructions are devoted to the production of drugs for clinical trials.