ПРАВИЛА РЕГИСТРАЦИИ И ЭКСПЕРТИЗЫ ЛЕКАРСТВЕННЫХ СРЕДСТВ В РАМКАХ ЕВРАЗИЙСКОГО ЭКОНОМИЧЕСКОГО СОЮЗА: ОЦЕНКА КЛЮЧЕВЫХ ИЗМЕНЕНИЙ

Abstract

The formation of a common pharmaceutical market within the framework of the Eurasian Economic Union requires the harmonization and unification of procedures for registration and examination of medicines. Changes made annually to the Rules for Registration and Expertise, their analysis and evaluation contribute to the optimization of this process. The goal is to evaluate the key changes made to the Rules for Registration and Expertise of Medicines over the past two years by a group of experts. Materials and methods. The expert group included 38 specialists with experience in registration of medicinal products and making changes to the registration dossier. The evaluation was carried out according to the Likert scale using the developed expert evaluation card. Results. It is shown that, in general, experts are very positive about the changes, both from the standpoint of their practical significance and the optimal ratio of stability and flexibility, and in terms of accuracy, correctness and clarity of formulations. Particularly noted were the creation of the necessary conditions for the active circulation of orphan drugs, their accelerated use in a number of individual cases, the increase in the availability of unregistered drugs in special cases, the exclusion of the annual re-evaluation of the “benefit-risk” indicator for a number of drugs, accelerating mutual recognition procedures in several Member States through simultaneous initiation. Conclusion. The strengths and weaknesses of the amendments to the Rules for Registration and Expertise of Medicines have been established. The need for a more detailed consideration of the amendments concerning the terms of the procedures for registration and expertise of medicines, as well as the assessment of changes in the annexes to the Rules, is shown.