Rethinking Regulatory Harmonization for Advanced Therapeutics:...

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2025-10-25 09:05:10 - Translate

Rethinking Regulatory Harmonization for Advanced Therapeutics: Streamlining Global Access to Gene, Cell, and RNA-Based Medicines

The emergence of revolutionary advanced therapeutic medicinal products (ATMPs), including gene therapies, cell therapies, and mRNA-based vaccines, has exposed significant fragmentation and inefficiency within the global regulatory landscape. These modalities, characterized by their immense complexity, patient-specific manufacturing processes, and unique risk profiles, often do not fit...

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