Abstract

TRENDS IN THE DEVELOPMENT OF THE EUROPEAN MEDICINES REGULATORY FRAMEWORK UNTIL 2025

A. Zlatareva* and B. Brankov

ABSTRACT

The aim of this review is to follow and analyze trends in the regulation of medicinal products in the European Union and the identified areas for the development of regulatory science for the next five years. Medicines policy, in particular the regulation of medicinal products, is subject to dynamic change in relation to the ongoing challenges imposed by the EC as a policy, but also by the local health systems as well as the economic ones of the Member States. The ultimate goal of any medicines policy of any Member State is to meet the interests of the main actors in a health system - institutions, industry, society, and patients must be at the heart of this health system. This inevitably leads to even higher requirements for policy makers to create working standards in medicines regulation to ensure timely access to innovative treatment for every European citizen in need.

Keywords: regulation, medicines policy / trends.