European Medicines Agency-Health Technology Assessment Parallel Consultation Platform: An Industry Perspective

The European Medicines Agency-Health Technology Assessment Body (EMA-HTAB) parallel consultation provides a forum for open dialogue among regulators, HTABs, patients, and sponsors on key clinical design elements early on in drug development. Increasingly, fostered by Industry as an efficiency toward ultimate availability of potential treatments for patients, reducing development program uncertainty through awareness of data requirements and likely market access outcomes can allow for optimal evidence generation in support of both regulator and payer decision making on benefit-risk and value.