Regulation (EC) No 726/2004

Regulation (EC) No 726/2004 establishes the procedures for authorizing, supervising, and monitoring medicinal products for human and veterinary use across the European Union. It created the European Medicines Agency (EMA), a central authority that assesses the safety, quality, and effectiveness of medicines, streamlining approval processes and ensuring consistent standards. The regulation aims to facilitate access to innovative medicines while maintaining high safety and quality standards, fostering collaboration among EU member states, and providing a transparent system for the authorization and oversight of medicines in the EU market.