Authors: Lagusani Yashwanth Goud, K. Susmitha
Abstract: Generic medications are becoming an essential part of contemporary healthcare due to the growing demand for reasonably priced medications. Despite efforts by the European Medicines Agency (EMA) to harmonize regulations, different European countries have different requirements for marketing authorization of generics. The regulatory framework for the approval of generic drugs in a few European nations, such as Germany, France, the United Kingdom, Spain, and Italy, is compared in this thesis. It draws attention to variations in bioequivalency standards, dossier submission requirements, approval schedules, and review processes. The results highlight the need for additional harmonization to improve patient access to reasonably priced medications and expedite generic drug market access.
DOI: http://doi.org/10.5281/zenodo.20442010
