In 2024, the Center submitted almost 15 thousand drug safety reports to the WHO international database

During 2024, specialists of the Center's Pharmacovigilance Department, as the organization authorized by the MoH of Ukraine in the field of post-registration safety surveillance of medicinal products:

• submitted 14 977 medicinal product safety reports to the WHO international database – global exchange of information helps to timely address any challenges related to the safety and efficacy of medicinal products at the international level;
• processed 16 296 reports of adverse reactions to medicinal products, vaccines, tuberculin, and/or lack of efficacy of medicinal products, and/or AEFI, received by the national pharmacovigilance database of the AIS – this demonstrates the commitment and interest of medical/pharmaceutical professionals in the safe use of medicinal products by patients;
• conducted expert evaluation of safety/efficacy and pharmacovigilance of more than 8,7 thousand registration dossiers for medicinal products submitted for state registration, re-registration and amendments in Ukraine;
• provided more than 1300 safety letters on medicinal products and vaccines to stakeholders, of which 642 to applicants regarding cases of adverse reactions/lack of efficacy;
• received more than 1800 periodic safety update reports (PSURs) for medicinal products from medicinal product applicants;
• published on the official website of the Center 251 safety communications on medicinal products based on the results of monitoring the websites of stringent regulatory agencies: EMA, FDA, MHRA and others;
• representatives of the Pharmacovigilance Center in the regions made almost 4000 individual visits to healthcare facilities, held 717 conferences, seminars and meetings at the level of regional health departments, delivered presentations at about a hundred scientific and practical conferences, and published 138 scientific and journalistic articles, information letters and methodological recommendations.