EMA offers enhanced support to non-profit drug developers

Written by | 10 Oct 2022 | Legislative and Regulatory

The European Medicines Agency (EMA) has launched a pilot 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 who are developing advanced therapy medicinal products (ATMPs). These medicines are based on genes, tissues or cells and might offer ground-breaking treatment options to patients.

The Agency said non-profit academics are a major contributor to the development of ATMPs and diagnostic and delivery devices but may find it challenging to navigate regulatory requirements.

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.

The pilot’s first participant has already been selected. This ATMP is ARI-0001, a chimeric antigen receptor (CAR) product based on patients’ own T-cells, that is developed by the Hospital Clínic Barcelona.

The pilot participants will benefit from all the available regulatory flexibilities and development support measures, such as fee reductions and waivers. The progress will be closely monitored, and initial results of the pilot are expected to be available in 3-4 years.

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