The guideline “Medicinal Products. Quality, Preclinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells” has entered into force in Ukraine.
In order to harmonize the regulatory framework in Ukraine regarding the development and evaluation of medicinal products containing genetically modified cells intended for human use and submitted for state registration, and based on the guidelines of the European Medicines Agency (EMA) on the quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells – “Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells”, EMA/CAT/GTWP/671639/2008 Rev. 1 – corr, November 2020, and on good clinical practice for advanced therapy medicinal products – “Guideline on Good Clinical Practice specific to Advanced Therapy Medicinal Products”, EC C(2019)7140 final – October 2019, specialists of the State Expert Center of the Ministry of Health of Ukraine have developed and published the guideline “Medicinal products. Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells” ST-N MOZU 42–7.12:2024, approved by MoH order of 16.02.2024 No. 264.
The guideline defines:
- quality aspects, preclinical and clinical aspects, safety and efficacy requirements for genetically modified cells;
- specific clinical considerations for CAR-T cells in onco-hematology;
- good clinical practice (GCP) for advanced therapy medicinal products.
The text of the new document can be found on the website of the State Expert Center of the Ministry of Health of Ukraine in the section "Guidelines and methodological recommendations for conducting preclinical and clinical trials" at the link
