Article summary
The European Medicines Agency (EMA) has announced it is launching a pilot to support academic and non-profit developers of advanced therapy medicinal products (ATMPs) and the translation of basic research developments into medicines to impact patients’ lives in the EEA. EMA notes that non-profit and academic developers are a major contributor to the development of diagnostic and delivery devices and ATMPs. The pilot will provide enhanced regulatory support for up to five ATMPs that address unmet clinical needs. The first pilot participant to be selected is ARI-0001, a chimeric antigen receptor product that is based on a patient’s own T-cells, as developed by the Hospital Clínic Barcelona. In addition, pilot participants will benefit from regulatory flexibilities and development support measures, ie fee reductions and waivers, with progress closely monitored. The initial pilot results are expected to be available in three to four years, along with a published report upon completion.
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