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Pharmacopoeial requirements constitute an indispensable and integral part of a quality assurance system for drugs. National approaches to the standardization of drugs are determined to a considerable degree by the level of national science development, equipment of laboratories, drug manufacturing technology, introduction of GMP regulations, and organization of control over the manufacture of substances. The article considers basic international trends in the development of requirements for the standardization of substances and distinctive features of national approaches to this problem.

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The status of "observer" received by Russia in the European Pharmacopoeia Commission provides an opportunity to use materials of Ph. Eur. However, there is no description of finished pharmaceutical dosage forms in Ph. Eur. Therefore, it is necessary to develop national approaches to evaluation of the quality, efficacy, and safety of medicines that conform to the international level of requirements. The article is dedicated to the problem of standardization of medicines in the pharmaceutical dosage form "tablets" that are intended for oral administration.

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