Current Criteria for Studies of Drug Bioequivalence: Harmonization of National Standards

Harmonization of national standards for drugs is one of the most relevant contemporary tasks for states, and the importance of this task for Russia increased with entry into the World Trade Organization (WTO). Apart from laws regulating medicines, a large body of subordinate legislation also requires review and updating. The guidelines for studies of drug bioequivalence are among the definitive normative documents for drug registration and quality control. The expert and medical communities are of the view that the current Russian guidelines do not meet international requirements and require revision. Some of the international criteria used in studies of drug bioequivalence are presented here. With the aim of increasing the quality of medicines on the Russian pharmaceutical market, we discuss current and proposed additional indicators for studies of bioequivalence for amendments and additions to allow documents to reach international standards.