EU Pharmaceutical Legislation Reform: Where Are We Now?

The European Commission proposed a significant revision of pharmaceutical regulations, marking a transformative shift in EU drug legislation. Key aspects include shortened automatic marketing exclusivity with provisions for extensions, a regulatory sandbox for innovative approaches, reduced approval timelines, and stricter management of medicinal product shortages. Notably, an Environmental Risk Assessment (ERA) will no longer be grounds for denying a Marketing Authorization Application (MAA), though compliance requirements for ERAs are enhanced.

The new legislation is currently under review by the European Parliament’s Health Committee (ENVI), with discussions highlighting concerns around exclusivity periods and regulatory flexibility for innovation. While ENVI aims to finalize amendments by April 2024 to accommodate the European elections in June, delays could push the process into late 2024.

The revised exclusivity framework proposes a baseline data protection period of 7.5 years, potentially extending to 11.5 years for products addressing unmet medical needs. Changes also extend orphan drug exclusivity to 11 years under certain conditions. Furthermore, adjustments to the EMA structure may impact transparency in decision-making, particularly regarding the roles of specialized committees.

ProPharma’s EU Regulatory Affairs team provides expert support to navigate these complex legislative updates, helping companies adapt their development strategies to ensure compliance and minimize risks. With additional regulatory influences from MDR, IVDR, and HTAR, ongoing monitoring is essential. Contact ProPharma to understand how our consultants can guide you through regulatory challenges to achieve successful product outcomes.