For combination products, the most expensive mistake is choosing the wrong regulatory pathway too late.
Two developments are reshaping strategy in 2026:
EU – Centralised Health Technology Assessment
The EU HTA Regulation, in force since 2025 for oncology medicines and ATMPs, is progressively expanding to additional product categories in the coming years.
This shift increases the importance of generating clinical evidence that can withstand scrutiny at a pan-European level, not just national payer review.
For drug-device combinations, evidence planning must now anticipate both regulatory approval and HTA evaluation much earlier in development.
United States – Early pathway clarity via Pre-RFD
The FDA’s Pre-Request for Designation (Pre-RFD) process allows sponsors to obtain informal feedback from the Office of Combination Products before formally committing to a regulatory route.
Determining whether a product will be led by CDER, CDRH, or CBER can significantly affect:
- Required evidence
- Development timelines
- Submission strategy
- Post-market obligations
Used early, Pre-RFD can prevent costly redesigns and regulatory delays.
For combination products, regulatory strategy is a core design decision from the earliest concept stage.
confinis advises global product teams on EU and US pathway strategy, designation, and integrated evidence planning. Get in touch!
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