Recent Developments and Insights on the EU Regulatory Data Protection System

On June 10, 2025, the Seminar on Strengthening Pharmaceutical Intellectual Property Protection to Promote High-Quality Development, hosted by the China Pharmaceutical News Association, was successfully held in Beijing. Miao Li, co-founder of IPDATALAB, delivered an engaging speech titled “Recent Developments and Insights on the EU Regulatory Data Protection System,” earning widespread praise.

Miao began by elucidating the essence and purpose of Regulatory Data Protection (RDP), highlighting its role in incentivizing pharmaceutical innovation, enhancing drug accessibility, and balancing industry development. She provided a comprehensive overview of the EU’s RDP framework, grounded in Directive 2001/83/EC, Regulation (EC) No 726/2004, Orphan Medicinal Products Regulation 141/2000, and Pediatric Regulation 1901/2006, detailing the European Medicines Agency (EMA)’s data protection for approved drugs, market exclusivity for orphan drugs, and incentives for pediatric medicines.

Miao then focused on the EU’s latest legislative developments, noting that challenges such as lengthy RDP periods, bias toward originator drugs, and lack of flexibility have prompted a new legislative proposal. Key amendments include shortening basic data exclusivity periods for new drugs, introducing flexible incentives for unmet medical needs, continuous supply of products, comparative clinical trials, etc., to improve drug accessibility, ensure supply stability, and address unmet clinical demands.

Concluding her speech, Miao drew implications for China, advocating for a cohesive IP and RDP system that balances originator and generic drug development while incorporating flexibility and diversity to foster industry growth and benefit patients and society.

Click here to access the presentation slides.