The European Medicines Agency (EMA) recently launched a pilot to support the translation of basic research developments into medicines that could make a difference in European patients’ lives. The pilot is open to academic sponsors and non-profit organisations who are developing advanced therapy medicinal products (ATMPs). They are a major contributor to the development of ATMPs and diagnostic and delivery devices, but experience has shown that navigating regulatory requirements can be challenging.
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 intends to 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. The pilot participants will benefit from all the available regulatory flexibilities and development support measures, such as fee reductions and waivers. Further details here.
Potential developer candidates can contact their national competent authority or EMA via firstname.lastname@example.org to express their interest in participating in the pilot or to receive more information.