EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products

The European Medicines Agency (EMA) announced the launch of a pilot to support the development of advanced therapy medicinal products (ATMPs).

One of the main objectives of the pilot will be understanding how EMA can optimize its interaction with and support to academic developers, focusing on their needs. To this end EMA will provide improved regulatory assistance for up to five selected ATMPs that address unmet clinical requirements, with the goal of optimizing ATMP development from best manufacturing practices through regulatory-compliant clinical development plans.

Key highlights

  • All regulatory flexibilities and development assistance measures, such as fee reductions and exemptions, will be accessible to pilot participants. The pilot's development will be constantly monitored, with preliminary findings expected in 3-4 years.
  • To indicate their interest in participating in the pilot or for additional information, potential developer candidates may contact their national competent authority or the EMA at advancedtherapies@ema.europa.eu.

Date: 26/10/2022 | Tag: | News: 1373 of 1626
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