5 Key Facts About EMA

If you are working in the pharmaceutical industry and are used to dealing with the US FDA, looking across the Atlantic might cause some bewilderment and confusion. The European Medicines Agency’s (EMA) place within the EU regulatory landscape, its set-up and workings can be puzzling to say the least, but this feeling should not have a negative impact on your plans for expanding your drug development or regulatory filing strategy to Europe.   Here are 5 key facts that just might improve your understanding of the EMA:   European Union 101 – The set-up You don’t need to be familiar with the intricacies of the set-up of the European Union, but understanding the EMA’s principle role in the EU regulatory landscape is essential. Think of EMA as a virtual agency set up in 1995 (in London) as a scientific consultancy to the European Commission (EC), the EU executive body located in Brussels. As such, EMA has no legal power to grant the actual marketing authorizations for the medicinal products they regulate – the agency’s remit is to do the medical and scientific assessment and to issue an opinion to the EC, who will base their ultimate (legal) decision on this scientific judgment. The goal of this new agency was to pool the best available scientific and regulatory expertise from all EU Member States for the assessment of the most innovative and cutting edge medicinal products. The scientific assessment is done by the 7 scientific committees (most notably the CHMP, but also PDCO, COMP and PRAC etc.) that meet at the EMA’s premises in Canary Wharf, London. However, the expert...