The European Medicines Agency (EMA) is launching a pilot for academics developing advanced therapy medicinal products (ATMPs) to support the translation of basic research developments into medicines that could make a difference in patients’ lives in Europe.
In this 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 of optimising the development of the ATMPs, starting from best practice principles for manufacturing to planning clinical development that meets regulatory standards. The pilot participants will benefit from all the available regulatory flexibilities and development support measures, such as fee reductions and waivers.
More information
Additional information can be found om the EMA website here.
Alternatively, potential developer candidates can contact their national competent authority or EMA directly via advancedtherapies@ema.europa.eu to express their interest in participating in the pilot or to receive more information.
