EMA Offers Pilot Scheme to Nurture Development of ATMPs
The European Medicines Agency has launched a pilot to help EEA based non-profit entities navigate the regulatory requirements to bring Advanced Therapy Medicinal Products (ATMPs) to market.
To be eligible for the scheme, the academic sponsor or non-profit organisation must be developing ATMPs which seek to address unmet clinical needs, with up to five ATMPs being taken on under the pilot.
Once enrolled, the entity will benefit from guidance throughout the regulatory process, including on manufacturing, clinical development, follow-up planning and safety issues, in addition to financial support in the form of fee reductions and waivers.
The aim of the pilot - which is expected to run for three to four years - is to assess what support or regulatory tool might be provided to convert more ATMPs to reach patients.
You can read the EMA's news bulletin on the pilot and how to apply for the pilot.