Specialists of the State Expert Center of the Ministry of Health of Ukraine were the developers of the updated standard, harmonized with the European EMA guideline, “Guideline. Medicinal Products. Clinical Evaluation of Vaccines” ST-N MOZU 42-7.14:2024 (MoH of Ukraine order of 08.08.2024 No. 1400).
The guideline will promote the use of innovative medical technologies and of modern international guidelines in the development, preclinical study, and clinical trials of new, highly effective and safe vaccines for the prevention of infectious diseases.
The document has been developed on the basis of guideline EMEA/CHMP/VWP/164653/05 Rev. 1 “Guideline on clinical evaluation of vaccines” — August 2023 (“Guideline on clinical evaluation of vaccines” — August 2023). The provisions reflect the current approach, harmonized within the EU and ICH, and are based on the latest scientific achievements in this field of knowledge. The guideline replaces the previous ST-N MOHU 42-7.7:2020 “Medicinal products. Guideline on clinical evaluation of vaccines.”
The guideline defines the general principles of clinical trials of vaccines with a view to their subsequent state registration. It applies to vaccines that are being developed (created), registered, and manufactured in Ukraine for medical use within the country and for the purpose of export or import. It concerns the planning and conduct of clinical trials of vaccines with regard to their efficacy, immunogenicity, and safety.
It is recommended for business entities engaged in the development, clinical study, and submission of applications for state registration of vaccines in Ukraine, regardless of departmental subordination and form of ownership; for the relevant applicants and manufacturers whose products are registered and imported into Ukraine; for scientific and expert organizations; for experts who conduct expert evaluation during state registration (re-registration) of medicinal products; and also for auditors and inspectors.
Compliance with its provisions by stakeholders such as applicants, registration certificate holders, developers and manufacturers of medicinal products, expert and regulatory bodies will increase the safety of clinical trials, contribute to improving the principles of ethics and reducing the use of laboratory animals, and accelerate the introduction of new medicinal products into medical practice.
The text of the guideline is available at the link http://surl.li/fgoyuz
