Procedure for Assessing Bioequivalence of Generic Medicinal Products Approved

An important regulatory legal act aimed at ensuring the safety and quality of medicinal products has been adopted in the Republic of Uzbekistan. In particular, by Order No. 26 of the Minister of Health of the Republic of Uzbekistan dated December 22, 2025, the “Regulation on the Procedure for Conducting Clinical Studies on the Pharmacokinetic Bioequivalence of Generic Medicinal Products and Evaluation of Their Results” was approved and registered with the Ministry of Justice (registration number — 3750).

This document was developed in accordance with Presidential Decree No. PF–137 dated August 19, 2025, and establishes mechanisms for the scientifically substantiated confirmation of pharmacokinetic bioequivalence, as well as the equivalence in safety and efficacy of generic medicinal products compared to reference (original) medicines during the state registration process.

According to the Regulation, mandatory clinical studies of pharmacokinetic bioequivalence have been introduced for certain types of generic medicinal products. These studies are aimed at a comparative assessment of key pharmacokinetic parameters — absorption, distribution, and excretion of the medicinal product in the human body — in comparison with the reference product. Based on the results, if the level of bioequivalence falls within the internationally accepted range of 80–125 %, the generic medicinal product is recognized as bioequivalent to the reference (original) medicine.

The document clearly defines the conditions for conducting clinical studies, criteria for participant selection, measures to ensure their rights and safety, as well as the procedure for evaluating study results. This ensures transparency, scientific objectivity, and patient safety throughout the clinical research process.

The order has been agreed upon with the Authorized Representative for the Protection of the Rights of Business Entities, the Committee for the Development of Competition and Consumer Rights Protection, and the Chamber of Commerce and Industry, and shall enter into force three months after the date of its official publication.

The new procedure, based on advanced international experience, enables the conduct of pharmacokinetic bioequivalence clinical studies of generic medicinal products in healthy volunteers and allows for obtaining scientifically reliable and statistically robust results within short timeframes. This is of significant importance in ensuring the availability of effective and safe medicines for the population, as well as in introducing fair competition and approaches compliant with international standards in the national pharmaceutical market.