Unified global standards for medicines: Myth or reality?

Abstract

This interview examines key aspects of harmonizing pharmacopoeial standards for medicines in the context of a globalized pharmaceutical market. The author analyzes the experience of international organizations (WHO, ICH, PDG) and assesses the feasibility of creating uniform global quality standards. Particular attention is paid to the development of the EAEU Pharmacopoeia, the principles of terminology unification, the development of the Nomenclature of Dosage Forms, and the methodological differences between leading pharmacopoeias (USP, Ph. Eur., BP, JP). The main barriers to full unification are identified: discrepancies in approaches to identification, impurity control, standardization of active ingredient content, and the issue of interchangeability of pharmacopoeial standard samples. The author concludes that a uniform global quality standard remains a long-term goal, while regional harmonization within the EAEU represents an effective and practical step toward converging regulatory requirements.