How does the EMA ensure the safety of medicines post-approval?
Post-marketing surveillance is a critical component of the EMA's safety monitoring activities. Once a medicine is approved and marketed, the EMA continues to monitor its safety through pharmacovigilance systems. This involves collecting and analyzing data on adverse effects reported by healthcare professionals and patients. The EMA also conducts periodic safety updates and can impose risk minimization measures if necessary. This ongoing vigilance helps to identify any long-term or rare side effects that may not have been apparent during preclinical and clinical trials, ensuring the continued safety of medicines.
