Since the establishment of an ATMP pilot program in September 2022, the EMA has accepted three academic and non-profit organizations working on advanced therapy medicinal products into the scheme, in which additional support is provided by the Agency.

The objective of the pilot program is to assist non-commercial developers of advanced therapies targeting unmet medical needs to navigate the regulatory and scientific requirements within the European Union. This effort facilitates the comprehension of requirements, the progress in medicine development and ultimately the application for marketing authorization. The EMA plans to expand this initiative by including two more developers by the end of 2024.

Chosen participants will benefit from fee discounts and waivers, as stated in the Decision of the Agency’s Executive Director on fee incentives for scientific advice, applications for marketing authorisation, and pre-authorisation inspections. 

Potential developer candidates can apply by completing the application form available on the EMA website or contact the Agency. Please follow the link below to find out more details.