What's Next For ATMP Regulation In EMEA

Securing EMA approval is only the first step for advanced therapy developers targeting the European market. The true challenge lies in navigating a fragmented landscape where each member state enforces its own regulations for pricing, reimbursement, and customs clearance. This complexity forces developers to manage different sets of bureaucracy in parallel, often leading to longer timelines for getting life-changing therapies to patients.

For tightly controlled, temperature-sensitive therapies like autologous cells, these inconsistencies are a direct threat to product integrity and timelines. The reality is that no single supply chain model can cover the entire region, requiring tailored, country-specific strategies. Until harmonization is achieved, developers must build supply chain plans that anticipate and adapt to these jurisdictional gaps, from selecting ports of entry based on local rules to ensuring customs documentation aligns with local expectations.

Gain essential insights into overcoming the logistical and regulatory hurdles across Europe and learn why early, comprehensive planning is critical to safeguarding product quality, managing risk, and achieving commercial scale.