The European Medicines Agency (EMA) welcomes the historic political agreement on the comprehensive reform of EU pharmaceutical legislation, marking the most significant regulatory overhaul in over 20 years. The reform aims to modernize how medicines are developed, authorized, and made available, making EMA and the EU medicines regulatory network more agile, efficient, and supportive of innovation while maintaining high scientific standards.

Key changes include:

• EMA will reduce its scientific committees from five to two, streamline assessment timelines (from 210 to 180 days), extend marketing authorizations by default, and implement mandatory digital submissions and electronic product information.

• Enhanced scientific advice with HTA bodies, regulatory sandboxes for innovative medicines, tailored frameworks for personalized therapies, and improved pediatric medicine processes.

• Obligations for continuous supply, shortage notifications and prevention plans, monitoring by EMA and national authorities, and an EU list of critical medicines.

• New requirements for environmental risk assessment, prudent antimicrobial use, and stewardship plans.

Overall, the reform is set to simplify procedures, foster innovation, ensure patient access to new treatments, strengthen supply security, and address public health challenges, including antimicrobial resistance.