Added on 25 September 2025:
'Working towards regulatory sandboxes' section
Innovation Task Force (ITF) briefing meetings provide developers an opportunity to engage in an early dialogue on innovative medicines with EMA.
The meetings assist developers in deciding on the next steps in their development programmes.
They complement existing formal EMA procedures and target all types of developers, including:
The meetings address regulatory, technical and scientific concerns arising from innovative medicines, technologies and methodologies.
Taking place earlier in the development process than scientific advice, they facilitate informal exchanges of information and guidance.
The meetings are free-of-charge and held virtually. They provide special support in the following areas:
An overview timeline of the application process is available below.
Find detailed information, and the documents necessary to apply, in the 'Documents' section on this page.
Requesting a meeting
Applicants should complete the ITF briefing meeting request form and send it to the ITF secretariat.
ITF briefing meeting request form and contacts are available further below.
Sending the briefing document
EMA may ask applicants to complete and send a briefing document.
EMA reviews the briefing document within 1-3 weeks and suggests the best way forward, which may include grant a meeting.
Registering in IRIS
If a meeting is granted, the applicant registers in IRIS and requests the creation of a research product identifier.
Drafting the meeting report
After the meeting, the applicant should draft a meeting report describing the topics discussed and outcomes of the meeting.
The meeting report template is available right below this section.
Submitting the draft meeting report
The applicant should upload the draft meeting report via IRIS within 10 working days.
A final version of the meeting report reviewed by the subject-matter experts will be uploaded to IRIS within 2-4 weeks of receipt of the draft version.
ITF briefing meetings cover regulatory, technical and scientific concerns arising from innovative medicines, technologies and methodologies.
Requests for meetings can be submitted at any time.
You can expect feedback within 1-3 weeks after submission of the request form.
The secretariat can request additional information via a briefing document or refer you to another service more suitable to your needs.
The secretariat provides available meeting dates within 4-6 weeks after the meeting has been approved. It also offers instructions and timelines for registration and submission of the required documents in IRIS.
These are examples of topics discussed at ITF briefing meetings:
The views expressed in ITF briefing meetings are the opinions of the participants and may not reflect the opinion of the EMA scientific committees.
Participants should interpret the answers provided as preliminary scientific and regulatory considerations of the information presented. These answers do not constitute regulatory guidance or review recommendations for any applications.
We advise you to phrase your topics accordingly. See the examples below:
EMA provides the applicant with a meeting report template including the list of participants.
EMA asks the applicant to prepare a draft meeting report within 10 working days after the meeting. This document should include the topics discussed during the meeting and the outcomes of the discussion.
Applicants submit the draft report in IRIS for participants to review. They provide comments on the draft meeting report which the coordinator reviews.
EMA uploads in IRIS a final version of the meeting report within 2-4 week of the receipt of the draft meeting report.
For human medicines, please use the following email address:
For veterinary medicines, please contact the secretariat via the following email address:
The European Commission, in its legal proposal for the revision of the EU pharmaceutical framework, has included a proposal for a ‘Regulatory Sandbox’.
A regulatory sandbox is a controlled framework that allows the testing of an innovative development in a controlled environment for a limited period of time.
The creation of a regulatory sandbox might be necessary when it is not possible to develop a medicinal product unless targeted adaptations or derogations to certain requirements are applied, under direct supervision of the relevant competent authorities.
The EC legal proposal is still under discussion with the Parliament and Council, and a final decision on inclusion of the Regulatory Sandbox in the EU pharmaceutical framework has not yet been reached.
However, as part of the Agency’s monitoring horizon scanning on future innovative products, informal ITF meetings with medicine developers may help to identify, at an early stage during development, potential case studies that could inform a regulatory sandbox approach in the future (if endorsed by the co-legislators). These meetings are: