Evaluation of Human Cell-Based Medicinal Products for Individual Use

Since 2024, SCEEMP is authorised to perform evaluation of human cell-based medicinal products intended for individual patients, which are produced directly at the medical organisation where they are used. The expert conclusion prepared based on the results of the evaluation informs the decision of the Ministry of Health of the Russian Federation on whether to grant authorisation for the manufacturing and use of human cell-based medicinal products for individual use.

Evaluation of human cell-based medicinal products for individual use is performed by SCEEMP in accordance with Article 32.1 of Federal Law No. 180-FZ ‘On Human Cell-Based Medicinal Products’ dated 23 June 2016 (as amended on 04.08.2023) as part of the fulfilment of the requirements of the following decrees of the Government of the Russian Federation:

– Decree No.384 of the Government of the Russian Federation ‘On Approval of the Rules for Regulation of Human Cell-Based Medicinal Products Intended for Individual Patients, Which Are Produced Directly at the Medical Organisation Where They Are Used’ dated 28 March 2024 (RU);

– Decree No.385 of the Government of the Russian Federation ‘On Approval of the Rules for Granting, Confirming, and Revoking Authorisation for the Manufacturing and Use of Human Cell-Based Medicinal Products for Individual Use’ dated 28 March 2024 (RU).

For more information regarding the conclusion of a contract for the evaluation of human cell-based medicinal products for individual use, please send your inquiries to expert_help@expmed.ru.

Guide on the Conclusion of a Contract for the Evaluation of Human Cell-Based Medicinal Products for Individual Use (RU) – 0.33 MB – PDF – Download

Procedure for Obtaining Authorisation for the Manufacturing and Use of Human Cell-Based Medicinal Products for Individual Use (RU) – 0.21 MB – PDF – Download

2025 Appendix 6. Model Contract for the Evaluation of Human Cell-Based Medicinal Products for Individual Use (for Budgetary Institutions) (RU) – 0.04 MB – PDF – Download

2025 Appendix 6. Model Contract for the Evaluation of Human Cell-Based Medicinal Products for Individual Use (for Commercial Organisations) (RU) – 0.04 MB – PDF – Download

Application Form for the Conclusion of a Contract for the Evaluation of Human Cell-Based Medicinal Products for Individual Use (RU) – 0.01 MB – PDF – Download

Documents

Decree No.384 of the Government of the Russian Federation ‘On Approval of the Rules for Regulation of Human Cell-Based Medicinal Products Intended for Individual Patients, Which Are Produced Directly at the Medical Organisation Where They Are Used’ dated 28 March 2024 (RU)

Decree No.385 of the Government of the Russian Federation ‘On Approval of the Rules for Granting, Confirming, and Revoking Authorisation for the Manufacturing and Use of Human Cell-Based Medicinal Products for Individual Use’ dated 28 March 2024 (RU)