The European Medicines Agency (EMA) has released a draft Guideline on quality, non-clinical, and clinical requirements for investigational advanced therapy medicinal products (ATMPs) in clinical trials for public consultation. This guideline outlines the structure and data requirements for clinical trial applications, covering both exploratory and confirmatory trials for ATMPs. It addresses multidisciplinary aspects including development, manufacturing, quality control, and both non-clinical and clinical development. The guideline details requirements for exploratory trials, such as First in Human studies, and confirmatory trials, with a view toward eventual Marketing Authorization Application (MAA). Feedback on the guideline should be submitted to AdvancedTherapies@ema.europa.eu.1
The draft guideline is available here.
References
- Committee for Advanced Therapies (CAT). (2024). Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal-products-clinical-trials-second-version_en.pdf
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