HARMONIZATION OF UKRAINIAN LEGISLATION ON PHARMACOVIGILANCE: CHALLENGES AND WAYS OF IMPLEMENTATION
DOI:
https://doi.org/10.11603/2312-0967.2025.4.15716Keywords:
pharmacovigilance, legislation, harmonization, Good Pharmacovigilance Practice (GVP), quality and safety of medicinesAbstract
Introduction. Pharmacovigilance in Ukraine is a critical component of the healthcare system. In the context of European integration, the harmonization of the national regulatory framework with EU legislation is a prerequisite for ensuring high standards of patient safety and integration into the European pharmaceutical space. The Order of the Ministry of Health (MoH) of Ukraine No. 898 dated December 27, 2006 (as amended by Order No. 996 dated September 16, 2016) was developed taking into account the European approaches of that time. However, significant updates to European legislation (GVP) in 2012 and 2017, as well as the adoption of the new Law of Ukraine "On Medicines" No. 2469-IX in 2022, have created a regulatory gap. Aligning domestic legislation with current EU norms and the new Law has become a primary task of today.
Aim. To compare the requirements for pharmacovigilance in Ukraine and the EU, identify discrepancies, and develop amendments to national regulatory documents to harmonize them with international standards.
Materials and Methods. The study employed bibliosemantic and analytical methods, the method of expert assessment, and modeling.
Results and Discussion. A comparative analysis of the current Procedure for Pharmacovigilance (Order No. 898) and the Law of Ukraine "On Medicines" (2002) against Directive 2001/83/EC, GVP EC recommendations, and the new Law No. 2469-IX revealed a number of inconsistencies. These concern both the terminological apparatus and the regulation of critical processes. The necessity of amending MoH Order No. 898, the "Guideline. Medicines. Good Pharmacovigilance Practices" (MoH Order No. 620), and MoH Order No. 650 regarding employee certification was established. Based on the analysis, the author proposed specific amendments to regulatory acts to eliminate discrepancies in safety monitoring, auditing, and reporting procedures.
Conclusions. The study confirmed the existence of systemic discrepancies in terminology and approaches to critical pharmacovigilance processes between Ukraine's current regulatory framework and current EU legislation. To ensure the proper functioning of the pharmacovigilance system and the implementation of the new Law of Ukraine "On Medicines," it is necessary to introduce comprehensive amendments to the relevant domestic regulatory acts, particularly regarding the updating of terminology, requirements for qualified persons, signal management, and safety reporting.
References
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