Specialists of the Center, headed by deputy directors, took part in a training webinar of the European Medicines Agency (EMA) dedicated to the new Guidelines of the European Commission on variations to the registration materials for medicinal products for human use (New Variations Guidelines for Human Medicines).
The training was held online and brought together representatives of regulatory authorities, experts and specialists from EU countries and candidate states.
During the training, participants became familiar with:
- procedural aspects of submitting variations;
- Section E – administrative changes;
- Section Q and M – changes relating to quality, as well as PMF/VAMF (plasma master file and vaccine antigen master file);
- Section C – changes related to safety, efficacy and pharmacovigilance;
- practical recommendations of EMA and CMDh on the application of new approaches.
Attended a question and answer session focused on typical regulatory challenges.
The guidelines on change management establish a unified, detailed and risk-based approach to change management, clarify their classification and submission requirements, strengthen consistency between quality, clinical and pharmacovigilance aspects, and also enhance the transparency and predictability of regulatory procedures. The guidelines will apply in the EU from 15 January 2026.
The participation of the Center's experts in such trainings is important in view of the harmonization of national regulatory approaches with EU law, preparation for the implementation of European requirements for change management, improving the quality of expert evaluation of registration materials and ensuring the transparency of regulatory decisions. The knowledge gained will become the basis for the further development of regulatory practice in Ukraine in the field of circulation of medicinal products.
