Multidisciplinary Study of the Quality of Medicines USA – Ukraine: The Role of the FDA and the National Regulator

Abstract

A multidisciplinary comparison of drug quality assurance systems in Ukraine and the USA is carried out with an emphasis on the role of the national regulator of drugs of Ukraine and the FDA. Strengths and weaknesses and ways of harmonization to strengthen trust in Ukrainian generics are identified. Analysis of FDA reports and inspections is used. Convergence of standards has been established. Ukraine: GMP-EU/PIC/S, SPhU 2.8 (more than 2000 monographs), renewal of inspections. USA: cGMP, USP (more than 5000 monographs, legal status), more than 1000 inspections annually. Cooperation with the FDA (USP Memorandum 2011, USP Convention 2025) complements the SFU with USP articles, improves pharmaceutical legislation, laboratory infrastructure and professional responsibility of pharmacists and doctors in the legal relationship "doctor-patient-pharmacist". Strengths of Ukraine: active removal of counterfeits, harmonization of Ph. Eur., protection of preferential programs. Weaknesses: Limited digital verification vs FDA Orange Book/DSCSA. Harmonization recommendations: mutual recognition of SPhU 2.8 and USP 48-NF 43; digital verification; expansion of laboratory capacity to FDA ORA level. State supervision in Ukraine and the United States forms a legal culture and protects patients' rights. Harmonization with the FDA ensures the competitiveness of Ukrainian generics, the safety of preferential programs and confidence in pharmaceutical services at the level of developed countries.