Respiratory drug-device combinations may look simple, but their regulatory pathway rarely are
Manufacturers must typically generate multiple parallel evidence streams, including:
🟦 Device performance testing
🟦 Pharmacokinetic or bioequivalence data
🟦 Human factors validation
Each jurisdiction applies its own thresholds and expectations.
Connected Inhalers add another regulatory layer.
When sensors or software are included, submissions must address medical device requirements for digital components in addition to the medicinal product dossier.
Environmental policy is also driving change.
The EU’s F-Gas Regulation is accelerating the transition away from high-GWP propellants used in many pressurised metered-dose inhalers. Reformulation efforts can require new evidence and device re-characterisation.
Raising the clinical bar.
In February 2026, the European Commission approved depemokimab as an ultra-long-acting biologic treatment for respiratory disease, reflecting increasingly robust evidence expectations for innovative therapies.
Respiratory products now sit at the intersection of drug, device, digital, and sustainability regulation.
confinis guides global teams through integrated regulatory planning across these domains!
While you focus on innovation, we take care of the regulatory path!
