EMA pilot offers enhanced support to academic and non-profit developers of ATMPS (GCT Catapult Regulatory Round-up – September 2022)

The EMA is launching a pilot scheme to support the translation of basic research developments into medicines that could make a difference in patients’ lives in the European Economic Area (EEA). The pilot is open to academic sponsors and non-profit organisations that are developing advanced therapy medicinal products (ATMPs).

During the pilot, EMA will provide enhanced regulatory support for up to five selected ATMPs that address unmet clinical needs and are solely developed by academic and non-profit developers in Europe. EMA will guide the participants through the regulatory process with the aim to optimise the development of the ATMPs, starting from best practice principles for manufacturing to planning clinical development that meets regulatory standards.

Potential developer candidates can contact their national competent authority or EMA via advancedtherapies@ema.europa.eu to express their interest in participating in the pilot or to receive more information.

See all of the Gene and Cell Catapult’s regulatory round-up for september 2022 here. Published on the 4th of October 2022.