30 років національній системі стандартизації, метрології і контролю якості лікарських засобів в Україні: основні досягнення, проблеми і перспективи розвитку

Abstract

Provision to every citizen, patient, and person in the system of legal relationship "doctor-patient-pharmacist" the right to life, health, and safety during the circulation of vital medicinal products of all clinical and pharmacological, nomenclature and legal, classification and legal groups, guaranteed by created in in Ukraine the system of standardization and quality control of medicines. The system of standardization and quality control of medicines includes the National System of Standardization of Medicines in Ukraine (1992); The system of state control of the quality of medicinal products (1992); Programs for the development of generic drugs in Ukraine (1995); The school of standardization and quality control of medicinal products; Center for standardization, metrology, and quality control in Ukraine. Ukraine got observer status in the European Pharmacopoeia in 1998. The National Pharmacopoeia of Ukraine (2001) appeared 6-7 years earlier than other countries (Belarus, Kazakhstan, Russian Federation). Two editions of the State Pharmacopoeia of Ukraine, totaling thirteen volumes and 7,208 pages, was developed as of 2022 and put into effect. The State Pharmacopoeia of Ukraine is fully harmonized with the European Pharmacopoeia and is the basis of the entire system of standardization and quality control of medicinal products in Ukraine. A pharmacopeial language (Ukrainian terminological apparatus), which did not exist before, was developed, and implemented. The State Pharmacopoeia of Ukraine is an important reference-informational and educational-methodical material for pharmaceutical enterprises, health care institutions, pharmacies, universities of medical and pharmaceutical profiles. The national system of pharmacopeial standard samples largely meets the needs of national control laboratories, and ranks the 6th in the world in terms of the number of pharmacopeial standard samples. The State Pharmacopoeia of Ukraine is the only pharmacopoeia in the world in which standardized validation procedures have been introduced, which has turned validation into an ordinary routine procedure. Ukraine acquired the status of a full member of the European Pharmacopoeia in 2013. European standards for the quality of medicinal products are in force in Ukraine. The State Pharmacopoeia of Ukraine acquired voting membership in the Pharmacopoeia of the United States in 2010. In order to develop texts that are not in the European Pharmacopoeia (in particular, monographs on ready medicines), the State Pharmacopoeia of Ukraine concluded Agreements with the leading pharmacopoeias of the world – the USA in 2010 and Great Britain in 2013. A powerful market, world- and European-level pharmaceutical industry was created, which was included in the field of health care, which provided the pharmacy network and health care institutions with modern, effective, safe, high-quality, and economically available drugs. The system of legal relations "doctor-patient-pharmacist" is based on the principles of pharmaceutical law, the Constitution of Ukraine, laws, and regulatory acts, timely ensures the right of a person, citizen, and patient suffering from various health disorders in accordance with the ICD-11, on life and health.