In 2025, the Center's specialists continued systematic work on identifying, analysing and preventing risks associated with the use of medicinal products. In the conditions of war, the pharmacovigilance system once again confirmed its ability to withstand challenges: medicines safety information continued to be received, analysed and used to protect the healthcare system and patients.
In 2025, the Center processed more than 100 thousand medicines safety reports. Of these:
- 16,7 thousand case report forms on adverse reactions following immunization (AEFI)/adverse reactions/lack of efficacy of medicinal products received from doctors/pharmacists/patients through the AISF system – the key national tool for collecting safety information;
- 84,3 thousand CIOMS reports from applicants – information that is an important component of assessing the benefit/risk balance of medicinal products.
In order for the Ukrainian pharmacovigilance system to remain synchronised with the global one:
- almost 15 thousand reports on adverse reactions to medicinal products and vaccines were submitted to the WHO global database;
- Based on the results of monitoring the websites of stringent regulatory agencies, more than 170 medicinal product safety notifications were prepared and published on the official website.
As part of ongoing interaction with the holders of registration certificates for medicinal products, the following were processed:
- more than 9,6 thousand registration dossier materials for medicinal products submitted for state registration/re-registration/changes, in order to identify potential risks in a timely manner at the stage of regulatory decisions.
- more than 2 thousand regularly updated safety reports (RUSRs) for 720 medicinal products.
- published on the official website of the Center 636 risk management plan (RMP) summaries and 310 pharmacovigilance communication materials, ensuring openness and accessibility of information for the professional community and patients.
The results of 2025 year confirm: the pharmacovigilance system remains a reliable tool for protecting patients and demonstrates further development taking into account new regulatory challenges and European integration processes.
