How does EMA ensure the safety of neonatal medicines?
The EMA ensures the safety of neonatal medicines through rigorous pre- and post-market evaluation processes. Before approval, medicines undergo extensive clinical trials to assess their safety and efficacy. Post-approval, the EMA continuously monitors the medicines through pharmacovigilance activities. This includes collecting and analyzing data on adverse drug reactions (ADRs) and taking necessary actions, such as updating safety information or even withdrawing a medicine if required.
