Ebook

The First Step on a Long Road Ahead: A Deep Dive into the JCA Implementing Act

The First Step on a Long Road Ahead: A Deep Dive into the JCA Implementing Act

Pages 8 Pages

This brief examines the draft Joint Clinical Assessment (JCA) Implementing Act under the EU Health Technology Assessment Regulation (HTAR). It explains what the Act clarifies regarding process, timelines, scoping, dossier submission, and stakeholder engagement—and what remains unresolved ahead of the January 2025 implementation. The brief highlights increased structure and formalization, including expert involvement and defined templates, while noting continued uncertainty around methodologies. IQVIA provides guidance on how health technology developers can prepare strategically for JCA participation and future EU market access requirements.

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