In the European Union (EU), the European Medicines Agency (EMA) plays a central role in the approval process for medications like Malegra. Companies seeking approval can choose between centralized and decentralized procedures, depending on whether they plan to market the drug in multiple EU countries simultaneously or through national authorities. The EMA evaluates data on quality, safety, and efficacy, ensuring alignment with EU standards. This process also includes pharmacovigilance measures to monitor the drug’s safety post-approval.