EMA-HTA Parallel Scientific Advice: Challenges and Opportunities

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The book explores the differences between regulatory agencies and health technology assessment (HTA) bodies in evaluating new medicines. It highlights how HTA bodies require additional evidence for reimbursement decisions, which can vary by country and include factors like unmet medical needs and cost-effectiveness. The text discusses the challenges posed by the evidence gap between regulatory approval and reimbursement, which can delay patient access to new drugs. It emphasizes the importance of early collaboration among industry, regulatory authorities, and reimbursement agencies in the drug development process.