EMA opens consultation on guideline for advanced therapies in clinical trials
The EMA on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs).
The 53-page guideline addresses development, manufacturing and quality control, featuring sections on quality documentation (including parts on the active substance and the investigational medicinal product), non-clinical documentation and clinical documentation.
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