EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines. The European Medicines Agency (EMA), in agreement with the European Commission, has ...
European Medicines Agency (EMA) welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines. These guidelines will ...
EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically. The European Medicines Agency (EMA) has created a ...