The Center held a workshop “All About Generics and Hybrids. What Is Similar and What Differs. Requirements for Demonstrating Properties”, organized by the Agency for Methodological and Scientific-Practical Work jointly with specialists of the Bioavailability and Equivalence Assessment Department.
The event was attended by applicants, regulatory affairs and medicinal product development specialists, researchers, and other professionals whose work is related to preparing materials for the state registration of medicinal products.
The purpose of the seminar was to give participants a systematic understanding of current requirements for demonstrating bioequivalence, the planning, conduct, and evaluation of comparative pharmacokinetic studies, as well as the preparation of registration materials in accordance with applicable regulatory requirements and international approaches.
During the training, the experts examined in detail the specifics of generic and hybrid medicinal products, the differences between the various types of applications for state registration, and the criteria for choosing the optimal regulatory pathway. Particular attention was paid to selecting and justifying the reference medicinal product, analyzing typical applicant errors, and practical algorithms for finding the necessary information.
Participants also became familiar with approaches to evaluating medicinal products with multiple strengths, reviewed practical examples for single-component and combination products, and received recommendations on determining whether a specific product belongs to generic, hybrid, or fixed-dose combination categories.
Значна частина семінару була присвячена питанням фармацевтичної еквівалентності, проведення порівняльних фармакокінетичних досліджень та застосування процедури біовейверу на підставі біофармацевтичної системи класифікації (БСК). Доповідачі проаналізували практичні ситуації та звернули увагу на нормативні документи, зокрема європейські рекомендації, які допомагають правильно формувати доказову базу під час державної реєстрації лікарських засобів.
The speakers at the event were Nadiia Zhukova, Candidate of Pharmaceutical Sciences, Director of the Department of Bioavailability and Equivalence Assessment of the Center, and Oksana Nahorniak, Head of the Bioavailability Materials Assessment Division.
The practical focus of the seminar and the analysis of real cases allowed participants to deepen their knowledge of the requirements for demonstrating bioequivalence, improve the quality of study planning and preparation of registration materials, and minimize the risk of typical errors during the state registration procedures for medicinal products.
At the end of the event, participants had the opportunity to ask the experts questions and discuss practical aspects of applying the current regulatory requirements.
