Business on Hold? EMA's Full Recovery in Question

ABSTRACT

The EMA pandemic Task Force (COVID-ETF) helps EU member states and the European Commission (EC) to take quick and coordinated regulatory action on COVID-19 treatments and vaccines. Delayed submissions As a result of pressure on the work time of regulators from COVID-19 matters, pharmaceutical companies are thought to be holding back the application for marketing authorizations of their products or approval of variations of marketing authorizations. Regulators are not only worried about having to grapple with a rush of delayed submissions but also the extra burden of implementing new EU legislation in areas like veterinary medicine, medical devices, and personal data protection. A joint HMA/EMA Big Data Task Force recommended in December 2019 that the regulatory network set up a platform for access and analysis of healthcare data from across the EU (5).