Advanced Therapy Medicinal Products (ATMP) Certification
What is it for?
It provides to SMEs developing ATMPs a formal assessment of the data they have generated to check that they are on the right track for successful development. It provides formal advice on how the existing data meet the requirements for marketing authorization. It aims to identify any potential issues early on, so that these can be addressed prior to the submission of a marketing-authorisation application. The outputs of this service are the ATMP Certificate, if granted, together with an evaluation report and EMA's Committee for Advanced Therapies (CAT) opinion. A possible follow up recommendation could be the advice to apply to some other EMA services (e.g. in case of a negative outcome: scientific advice recommendation for re-application to the certification as the development proceeds) and when. More information can be found at the EMA website here.
Who can apply?
This support service is open to any SMEs EIC beneficiary working on gene and cell therapies, and tissue engineered products and with some generated data on pharmaceutical quality and, optionally, on non-clinical aspects.
How to apply?
Applications need to be submitted in English via EMA Service Desk. In EMA Service Desk, please select “Pre-submission phase request” under “Type of question”, followed by “ATMP certification” to submit your request. To notify EMA of an intention to submit an ATMP certification request, complete the “Intent to submit” pre-submission request form below and submit it via EMA service desk: Presubmission request form: intent to submit. To request an ATMP certification, complete the “ATMP certification” pre-submission request form and list of annexes below and send these together with all the annexes composing the ATMP certification dossier via EMA service desk:
After validation, re-submit the ATMP certification dossier via Eudralink to the CAT members and via EMA service desk. For more information please check 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). Fee will be charged depending on whether there is non-clinical data to be evaluated or not. For more information on the fee please check here. 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 learn more on ATMPs please check the Support for advanced-therapy developers.
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/research-development/advanced-therapies/advanced-therapy-development/certification-procedures-micro-small-medium-sized-enterprises-smes#how-to-apply-section
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