Advanced Therapy Medicinal Products Classification

What is it for?

It provides the informal recommendation from the EMA's Committee for Advanced Therapies (CAT) on whether a medicine being developed meets the scientific criteria of an Advanced therapy medicinal products (ATMP), and thus whether it is classified as a gene, cell or tissue engineered medicinal product. The outcome will be published in the EMA website. A possible follow up recommendation could be the advice to apply to some other EMA services (e.g. scientific advice or ATMP certification) and when. More information can be found at the EMA website here. 

Who can apply? 

This support service is open to any EIC beneficiary working on the early-stage development (no expectation of non-clinical or clinical development) of a medicine that could be classified as an ATMP. 

How to apply?

To apply send the ATMP Classification Information Sheet and ATMP Classification Request Form and Briefing Information to atmpclassification@ema.europa.eu. More information can be found here. An SME needs to have received the SME status from EMA to benefit from this free service. Please check here to find out how to obtain it.

Timeline and Cost

One can apply any time (no requirement on having an EIC project ongoing or having had one) and the service is free of charge to SMEs and Academia. The service will be offered upon acceptance of the application by EMA. The entire process from the application receipt to completion takes 2 months.

Learn more

To know more please watch here the recording of the EIC – EMA InfoDay: Regulatory support for the development of innovative medicines and technologies offered on 31/01/2023. The presentation on ATMP starts at 55 min and is at slide 20th of the presentation to be found here. 

For more information please check: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/advanced-therapies/advanced-therapy-classification

To learn more on ATMPs support please check the Support for advanced-therapy developers.

Contact 

EMA contact entry points if you are still uncertain to which service you should apply, and when or how to apply:

Entry point for SMEs:                        Entry point for academia:
SME@ema.europa.eu                         Academia@ema.europa.eu
Helpline +31 (0)88 781 8787