GAP-analysis and SWOT-analysis of pharmacopoeial quality standards of Calendulae flos: experience of Ukraine and France

The article considers the issue of harmonization of requirements for standardization of medicinal plant raw materials using the example of Calendula officinalis flowers in the context of the State Pharmacopoeia of Ukraine and the Pharmacopée française. Introduction. The relevance of the topic is substantiated in connection with the need to improve the quality, safety, and competitiveness of domestic herbal medicines, as well as the integration of Ukraine into the European pharmacopoeial space. Purpose. The purpose of the study was to conduct a comparative analysis of the requirements of the State Pharmacopoeia of Ukraine and the Pharmacopée française for Calendulae flos, identify the strengths and weaknesses of domestic regulation and formulate recommendations for harmonization with European standards. Materials and methods. Methods of comparative analysis of regulatory documents, GAP (Gap Analysis Process), and SWOT (Strengths, Weaknesses, Opportunities, Threats) analyses were used to identify differences and similarities in the requirements for identification, purity, and quantification of marker substances. Additionally, data from the European Pharmacopoeia, the World Health Organization and the European Medicines Agency were used as a reference base. Results and discussion. Shown that the State Pharmacopoeia of Ukraine contains basic requirements for macro- and microscopic characteristics, thin-layer chromatography and purity indicators, but less detailed identification tests, a limited list of purity indicators and a narrower approach to quantification compared to the Pharmacopée française. The French Pharmacopoeia, unlike the Ukrainian one, focuses on specific marker compounds (flavonoids, carotenoids), control of impurities (including pesticides and heavy metals) and modern methods of analysis. SWOT analysis revealed the strengths of both systems, but showed the need to improve domestic standards. Conclusions. The analysis confirmed that the harmonization of the State Pharmacopoeia of Ukraine with the Pharmacopée française and the European Pharmacopoeia is an important condition for increasing the level of standardization of medicinal plant raw materials in Ukraine. The introduction of modern identification methods, expanding the list of marker substances and purity indicators will help guarantee the safety and effectiveness of medicinal products of herbal origin, and will also strengthen the competitive position of domestic products on the international market.