The European Medicines Agency (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.
Background
According to the guideline, advanced therapy medicinal products (ATMPs) include gene therapy, somatic cell therapy medicinal products and tissue engineered products.
“In general, the development of an ATMP should follow the same general principles as other medicinal products,” EMA says. “However, it is acknowledged that the distinctive characteristics and features of ATMPs are expected to have an impact on product development.”…
