European Medicines Agency (EMA) News Channel
Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring. Supporting the rapid development and approval of effective and safe treatments for and vaccines against COVID-19 is EMA's top priority to help save lives during the pandemic. Over recent weeks and months, the Agency has engaged with many developers of therapeutic medicines and there are a number of developments underway. EMA's human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ervebo (rVSVĪG-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus. EMA's human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. EMA's Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. This is one of the findings of a joint EMA/FDA analysis comparing decisions on 107 new medicine applications at the two agencies between 2014 and 2016. The study also looked at applications for which the agencies had differing outcomes in terms of type of approval and indication. The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).