The guideline "Medicinal Products. Clinical Evaluation of Vaccines" has come into force in Ukraine.
In order to harmonize the regulatory framework in Ukraine on the clinical evaluation of vaccines intended for the prevention of infectious diseases, and on the basis of the European Medicines Agency (EMA) guideline EMEA/CHMP/VWP/164653/05 Rev. 1 "Guideline on clinical evaluation of vaccines", — August 2023 ("Guideline on clinical evaluation of vaccines", — August 2023), specialists of the State Expert Center of the Ministry of Health of Ukraine have developed the guideline "Medicinal Products. Clinical Evaluation of Vaccines ST-N MoHU 42–7.14:2024", approved by order of the Ministry of Health of Ukraine dated 08.08.2024 No. 1400, to replace the guideline "Medicinal Products. Guideline on Clinical Evaluation of Vaccines ST-N MoHU 42-7.7:2020", approved by order of the Ministry of Health of Ukraine dated 11.08.2020 No. 1848, which has been repealed.
The guideline addresses:
- issues concerning the design of vaccine immunogenicity trials;
- basic requirements for the study of clinical efficacy;
- assessment of vaccine effectiveness;
- recommendations on the assessment of vaccine safety in clinical trials.
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
