Simplification of procedures required for registration of medicines

Abstract

A poster presentation regarding the simplification of procedures required for registration of medicines. Introduction: A medicine requires a Marketing Authorisation (MA) before it could be made available on the EU market (Directive 2001/83/EC). This registration process ensures the safety, quality and efficacy of medicines on the market. The requirements to obtain a MA are complex and may adversely influence accessibility to medicines. The problem of accessibility to medicines is of particular interest to small countries such as Malta. The availability of high quality medicines that are not very expensive promotes confidence in health systems, health care professionals and the pharmaceutical industry. The research question of this study was: Can registration of medicines in small EU countries such as Malta be simplified? Aims:  To review the processes by which medicines are registered in the EU, with particular interest to small countries  To analyse the strengths and weaknesses of registration processes and identify challenges in the registration process in Malta  To compile a guide intended to simplify the process for the registration of medicines in Malta and in small EU countries