Insights

Startups entering the European market face a critical challenge: limited resources demand a clinical development strategy that serves both regulatory and reimbursement objectives-simultaneously. 

🔗 One Strategy, Two Audiences 

From the earliest stages of development, regulatory and market access considerations must be aligned. A successful strategy should address: 

• ✅ Endpoints that meet EMA requirements 

• 💶 Comparators, patient data, and health economic evidence that satisfy EU payers 

This alignment is no longer optional. With the implementation of the Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282, all new oncology and advanced therapy medicinal products (ATMPs) centrally authorized by EMA will undergo a mandatory EU-level clinical evaluation starting January 2025.

The rollout continues with: 

• Orphan drugs included from 2028 

• All other centrally authorized products from 2030 

The JCA aims to harmonize clinical evidence requirements across member states, streamlining the path to market access and reducing duplication of effort. 

💡 Efficiency Through Integration 

An integrated approach is not about increasing workload—it’s about working smarter. This method: 

• Reduces risk across European operations 

• Enhances investor appeal 

• Ensures readiness for market access once regulatory approval is secured 

🌍 Capital-Efficient Planning for Europe 

Separate strategies for regulators and payers are no longer feasible. A unified, efficient plan is essential to navigate the European landscape effectively—especially in light of the JCA’s structured timelines and consolidated evidence expectations. 

Let’s connect at RAPS Convergence in Pittsburgh, October 7–9.
Lucia Piampiani, Market Access Director at RPN, will be available at Booth #436 for a complimentary strategy session to explore how startups can build integrated, capital-efficient plans for Europe.