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This is a Systematic Review study.

September 10, 2025BioDrugsOpen Access

Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024

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41.5% of post-authorisation measures for ATMPs used real-world data to assess safety and efficacy.
Data extraction from European Medicines Agency documents identified 118 post-authorisation measures across 25 ATMPs.
The majority of real-world data measures were imposed by the European Medicines Agency, demonstrating regulatory flexibility.
Incorporation of real-world data may enhance regulatory decisions and address uncertainties surrounding advanced therapies.

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Systematic analysis reveals that 41.5% of post-authorisation measures used real-world data, highlighting regulatory flexibility.

Almeida et al. (2025) studied this question.

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