The EMA has updated its practical guidance for pharmaceutical companies for procedures related to Brexit

From 30th March 2019, when the United Kingdom’s (U.K.) is expected to withdraw from the European Union (EU), all EU law will no longer apply to the U.K. The European Medicines Agency (EMA) and the European Commission have therefore published additional practical guidance to help pharmaceutical companies legally prepare for this transition. This guidance will…

EMA and EUnetHTA publish a 3 year collaboration plan to improve efficiency and quality

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have finalised “a joint work plan outlining key areas of collaboration for the next three years”. The main areas of collaboration are information exchange at market entry, data generation post approval and early dialogue. These areas are expected to also provide…