Innovation Task Force (ITF) Briefing Meeting
What is it for?
It provides multidisciplinary informal regulatory and legal advice from experts and EMA staff to support the development of any innovative methods and technologies in health, and any medicines. Free advice will be provided in the form of a dialogue (1.5 h brainstorming meeting with experts from the EMA network, working parties and committees) as well with a final report with the expert’s recommendations and considerations. A possible follow up recommendation could be the advice to apply to some other EMA services (e.g. scientific advice) 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 at early stage (after proof of concept) for innovative technologies, substances and methods related to medicines development. However, ITF is available at any stage of development for those that are particularly innovative or disruptive. ITF also covers the regulatory acceptance of so-called new approach methodologies (NAM) to replace the use of animals in the testing of medicines, in line with the 3Rs principles (replacement, reduction, refinement).
How to apply?
To apply send the 3-page ITF Briefing Meeting request form to itfsecretariat@ema.europa.eu for human medicines, or itfvet@ema.europa.eu for veterinary medicines. More information can be found here including a step by step application guideline.
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 application to completion takes between ~ 3-4 months (the timing depends also on the applicant promptness in providing the information requested).
Testimonials
Please read here and watch (from 1 h 36 min to 1 h 46min) the testimonial from the coordinator of the EIC Pathfinder EVO-NANO project.
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 ITF starts at 1h 09 min and ends at 1h 36 min. The slides of the presentation can be found here.
For more information please check: https://www.ema.europa.eu/en/human-regulatory/research-development/innovation-medicines#itf-briefing-meetings-section
FAQ
FAQ on the ITF as part of those Qs asked during the EIC – EMA Info Day will be posted soon at the InfoDay event webpage.
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