Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Bioequivalence requirements in the Eurasian Economic Union, the European Union, the United States of America and the People’s Republic of China

Aksana Müller (Abschlußjahr: 2018)

Summary
Generics play a vital role in the healthcare systems across the world. The requirements to obtain marketing authorisation of a multi-source pharmaceutical product depends on the regulatory framework applied by the regulatory agency of each country.
To ensure interchangeability between an original branded medicine (innovator) and generic drugs regulatory authorities require that generics have to be bioequivalent. National regulations set the conditions for the conducting of bioequivalence studies but there is no consensus between the various countries.
The objective of this master thesis is to discuss the similarities and differences among bioequivalence approaches used by regulatory authorities Russia, Belarus and Kazakhstan and unified guidance for bioequivalence studies of the Eurasian Economic Union, and also requirements of the European Union, the United States of America and China.
The following bioequivalence approaches have been compared: definitions and terms e.g. a generic and reference product, subjects of bioequivalence study, recommended study designs, fasting and fed studies, single and multi-dose studies, bioequivalence acceptance limits and biowaivers.
Special attention is given to the several significant changes in the bioequivalence legislation of Eastern European countries and China over the last years.
Pages: 54