EMA experts meet with African regulators to discuss opportunities for collaboration

How to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools?

These were two of the questions discussed at a workshop jointly organized by the European Medicines Agency and the Maltese Presidency of the European Union that brought together regulators from across the EU and Africa in Malta earlier this month.

One of the tools discussed was the scientific assessment of medicines or vaccines for use outside the EU that EMA can conduct in line with European legislation (under the so-called ‘Articles 58’ procedure). These assessments are carried out in cooperation with the World Health Organization (WHO) and aim to increase access by patients in low- and middle-income countries (LMICs) to high quality, safe and effective medicines. The overall goal of this procedure is to contribute to improving global health.