What HTA Bodies Can Learn from the EMA About Joint Clinical Assessments
Experts speaking at a gene and cell therapy conference have highlighted the need for greater flexibility in EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation, particularly regarding evidence requirements. The European Medicines Agency’s (EMA) approach to non-traditional studies should serve as a model for the joint clinical assessment process.
By adopting a more flexible approach to evidence evaluation, HTA bodies can better align with the EMA’s progressive stance on innovative clinical trial designs. This alignment is essential for streamlining the approval process for advanced therapies and ensuring that patients have timely access to potentially life-changing treatments.
