The Ukrainian pharmaceutical sector is actively preparing for a large-scale reformatting. Starting in January next year, a new single regulatory body will begin operating in Ukraine, so the Center's specialists are intensively studying the regulatory policies and practices in force in the EU.
Recently, experts in registration, pharmacovigilance, bioavailability and equivalence assessment, and compliance conducted practical training with European colleagues from Croatia and Lithuania within the Twinning project. The meeting was held in a question-and-answer format with the analysis of real practical cases.
Among the key issues discussed:
- Registration procedures and dossiers – specifics of registration of certain groups of products, lifecycle;
- Safety and marketing requirements – implementation of 2D-coding on packaging and European approaches to medicinal product quality control;
- Laboratory control and inspections – rules for referring medicinal products to laboratories and integration of GMP/GLP/GCP standards checks;
- Cost assessment and financing – transparent administrative algorithms, interaction of expert commissions, and use of IT systems for monitoring the medicinal products market;
- Overcoming conflicts of interest – European standards and declaration rules during the expert evaluation of materials;
- Practices of interaction with manufacturers' associations in cases of emergency needs for medicines in wartime and/or to provide for vulnerable categories of patients.
The mentors were: Head of the Medicinal Products Licensing Department of HALMED Maja Lovrek Romčević, Adviser of the Pharmaceutical Activities Department of the Ministry of Health of Lithuania Kristina Povilaitienė and Chief Specialist of the Marketing Authorisation Division of the State Medicines Control Agency of Lithuania Viltė Šilkaitytė.
We thank our partners for their valuable knowledge and experience – the knowledge gained will help in developing the necessary regulatory amendments to legislation in Ukraine, and will also contribute to greater readiness for the work of the new regulatory authority.
Further enhancement of the competencies and institutional capacity of the Center's specialists continues – right now a team of experts from the Center is on a working visit to Vilnius (Lithuania), where they are studying the European pharmacovigilance system in greater depth.
