Advanced Therapy Medicinal Products (ATMP) and Regulatory Clarity

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2026-01-21 10:08:54 -

The European regulatory landscape for nucleic acid therapeutics is governed by the Advanced Therapy Medicinal Products (ATMP) framework. This specialized legislation provides a clear pathway for the approval of gene therapies, somatic cell therapies, and tissue-engineered products. By centralizing the approval process through the EMA’s Committee for Advanced Therapies (CAT), Europe offers...

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