Read related content in the entry on marketing authorisation or on early interactions between competent authorities and stakeholders of the research pathways.
The EMA is the agency dedicated to promoting and protecting human and animal health in the European Union. This agency is responsible for the scientific assessment. Because of the complexity of ATMPs the EMA has a unique responsibility to provide scientific evaluation of new and existing treatments, not just for European Union (EU) members but also for countries in the European Econocomic Area (EEA). The European Medicines agency only covers medicines, not medical devices.
Read related content in the entry on marketing authorisation or on early interactions between competent authorities and stakeholders of the research pathways.