The European Medicines Agency's Committee for Advanced Therapies (CAT) is scheduled to meet from 11 to 13 May 2026 to discuss scientific and regulatory issues related to advanced therapy medicinal products (ATMPs). The agenda includes the review of marketing authorisation applications, classification and certification of ATMPs, and updates on ongoing scientific guidelines.
The CAT is responsible for assessing the quality, safety, and efficacy of gene therapies, cell therapies, and tissue-engineered products, which are subject to EU centralised marketing authorisation. The meeting will also address follow-up measures from previous assessments and provide recommendations to the Committee for Medicinal Products for Human Use (CHMP).
Stakeholders affected include developers of ATMPs, patients awaiting innovative treatments, and national competent authorities. The outcomes of the meeting may influence future regulatory pathways for advanced therapies in the EU. No prior coverage of this specific meeting exists.
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