Author: PD Dr. Ghazaleh Gouya-Lechner, Founder, Gouya Insights | Last reviewed: June 2026
Most biotech and medtech developers or academic spin-offs entering the EU regulatory system for the first time do not know where to start. Which pathway applies to their product? When should they contact the European Medicines Agency (EMA)? What do they need to have ready before making that call? This article answers those questions and introduces the tool the EMA has built specifically for this moment, one that most early-stage teams never use.
Most early-stage founders approach regulatory agencies when a problem appears: when a submission is rejected, when an investor requires a regulatory opinion, or when a clinical trial application triggers unexpected questions. This pattern is one of the most reliably expensive mistakes in development.
The European Medicines Agency (EMA) is direct about this. “Engaging with us early will probably save you time and money, and we’re not just saying that as a slogan, we actually mean it,” said Emmanuel Cormier, Head of the Regulatory Science and Innovation Task Force at the EMA, in a 2025 LinkedIn Live session.
The data behind that statement is concrete. Small and medium-sized enterprises (SMEs) and academic groups that do not engage early show a measurably higher rate of major objections in their Marketing Authorization Application packages. The consequences are remediation studies, timeline extensions, and in some cases program termination, at the point in development when failure is most expensive. By the time a Marketing Authorization Application is submitted, the clinical and nonclinical program is complete. Course correction is no longer a strategic choice; it is a crisis.
Engaging before development decisions are locked is when early EMA contact has the most value. At the stage of indication selection or early preclinical development, the program is still flexible. A single early interaction can clarify whether a proposed primary endpoint is acceptable, whether an animal model is considered translatable, or whether an accelerated pathway like PRIME is worth pursuing, all before a single patient is enrolled.
The Innovation Task Force (ITF) is a multi-disciplinary group within the EMA that holds informal briefing sessions with developers of novel medical products. A session typically lasts between one and one and a half hours and is structured as a focused discussion.
The EMA assembles internal experts relevant to your specific product type, from clinical pharmacology and regulatory science to advanced therapies or device regulation.
The ITF is not a formal regulatory procedure. The EMA does not issue a binding opinion, a written regulatory position, or any form of approval at an ITF meeting. What you receive is early insight into how regulators are likely to think about your product: its classification, the evidence standard that will likely apply, and whether the pathway you are assuming is the right one. The ITF tells you whether your regulatory assumptions are correct before they become too costly to change.
The ITF was originally designed for developers working on advanced therapy medicinal products (ATMPs), including gene therapy, cell therapy, and tissue-engineered products, as well as orphan medicines and products built on novel technology platforms. Its scope has since expanded. Medical device and in vitro diagnostic (IVD) developers can also request an ITF meeting when their product sits at the boundary between regulatory categories. Drug-device combinations, companion diagnostics, and AI-driven or digital health tools that influence clinical decision-making are all appropriate candidates. If your product is a straightforward medical device with a clear MDR classification, a notified body is the right starting point. If the classification itself is uncertain, the ITF is.
Requesting an ITF meeting does not initiate a regulatory procedure, trigger any formal timeline, or constitute a regulatory submission. The ITF is free of charge for all developers.
Next step: If you are genuinely uncertain whether your product is regulated as a drug or a device, contact the EMA SME Office before deciding which engagement route to take.
A common assumption among US-based founders is that EMA engagement tools are only accessible to European companies. That is not the case. Non-EU companies, including those based in the US, can access the ITF and other EMA support mechanisms through regulatory consultancy, a specific access route for companies incorporated outside the European Economic Area who wish to develop products for the EU market. The EMA SME Office handles eligibility questions and can advise on which tools and fee incentives apply to your situation.
For US biotech founders considering the EU as a development or commercialization market, the ITF is a low-commitment, zero-cost way to understand what the EU regulatory pathway would look like for your product before committing to a full EU development strategy.
Next step: Contact the EMA SME Office to confirm your eligibility before submitting an ITF request.
Late preclinical development is the right time for an ITF meeting. You have enough biology to ask specific questions, but you have not yet committed so much capital that the answers can no longer influence the program.
The ITF’s value lies in its ability to shape decisions that are still open. If you arrive with a completed toxicology program, a locked protocol, and a fixed indication, you can still receive useful feedback, but implementing that feedback may require major changes at significant cost. The program has already been built around assumptions that may not align with regulatory expectations.
In practice, the right moment to request a meeting is when you can answer the following in a briefing document: what the product is and how it works, what disease or condition you intend to address, and what specific regulatory uncertainties you need to resolve. You do not need a complete data package. The EMA is explicit that developers should reach out first and then clarify together what to bring.
“Innovators and regulators are actually two sides of the same coin. We're part of the process of innovation, not a step in the process.”
The EMA wants to hear from you earlier than you think. Emmanuel Cormier, Head of the Regulatory Science and Innovation Task Force, put it directly in a 2025 LinkedIn Live session.
Next step: Use the guided self-assessment in the Indication Selection white paper to test whether your program is ready for an ITF briefing package.
The process is simpler than most founders expect. You submit a short briefing package to the EMA describing the product, the innovation, and the specific questions you want to discuss. It does not need to be a comprehensive dossier. It needs to be focused enough that the EMA can assemble the right internal experts and prepare a meaningful response.
After submission, the EMA reviews the package within one to three weeks and confirms whether a meeting is granted. If it is, available meeting dates are provided within four to six weeks. The meeting itself is a focused discussion. You present your technology and your questions; the EMA experts respond with their current thinking. Because the interaction is informal, regulators can share perspectives they would not put into a formal written opinion, including uncertainty and evolving thinking on novel areas. After the meeting, you draft a meeting report within ten working days, and the EMA returns a final reviewed version.
A briefing package should include: a concise description of the product and its mechanism, the therapeutic area or device application you intend to address, the specific regulatory uncertainties you need to resolve, and a brief summary of your current development stage. A complete nonclinical or clinical data package is not required at this stage.
The ITF is free of charge for all developers and takes between three and seven weeks total.
Next step: Find the request form, step-by-step instructions, and secretariat contact on the EMA’s official ITF page. Verify current procedures with the EMA SME Office before submitting.
The ITF produces informal guidance, not binding regulatory positions. You cannot cite an ITF discussion as regulatory agreement in a Clinical Trial Application or a Marketing Authorization Application. If you need documented regulatory alignment on a specific question, a trial design, an endpoint, or a nonclinical package, that conversation needs to happen through Scientific Advice, which is formal, procedurally defined, and produces a written position.
Three mistakes account for most of the value lost in ITF meetings.
Three questions to ask before requesting an ITF meeting: Do I know my product category? Do I have specific regulatory uncertainties? Have I prepared a focused briefing document?
| Common Mistake | Why It Matters | What to Do Instead |
|---|---|---|
| Requesting the meeting too late | Most development decisions are already locked; feedback adds cost rather than value | Request during late preclinical, before the Clinical Development Plan is finalized |
| Arriving with unfocused or broad questions | The EMA cannot assemble the right experts or prepare a meaningful response | Identify three to five specific regulatory uncertainties in advance |
| Expecting a binding regulatory position | ITF output is informal and cannot be cited in submissions | Use the ITF to scope your questions; follow up with Scientific Advice for formal alignment |
| Not preparing a focused briefing document | Meeting covers too much ground superficially | Submit a concise package: product description, indication, specific questions |
| Treating the ITF as a one-time interaction | One meeting rarely resolves all regulatory uncertainty | Plan the ITF as the first step in a structured engagement sequence |
The ITF is for early-stage classification and pathway questions where regulatory guidance is genuinely unclear. Scientific Advice is for formal alignment on specific development questions once you know your pathway and have a developing data package. The ITF typically precedes Scientific Advice, and a well-executed ITF meeting will clarify exactly which questions to bring to Scientific Advice and whether you are ready to do so.
| Feature | ITF | Scientific Advice |
|---|---|---|
| Purpose | Informal early guidance on classification, pathway, and key uncertainties | Formal written opinion on quality, nonclinical, or clinical development questions |
| Output | Record of discussion (not binding) | Written regulatory position (binding) |
| Cost | Free for all developers | Fee applies; significant reduction for SMEs |
| Data package required | Concise briefing document; no complete dataset needed | Developed data package required |
| Best timing | Late preclinical, before Clinical Development Plan is finalized | After preclinical program is defined; before or during Phase I |
| Can be cited in submissions | No | Yes |
The ITF is the entry point into a structured sequence of regulatory interactions. After an ITF meeting, the typical next steps depend on what was clarified. If the ITF confirms that a conventional regulatory pathway applies and the development plan is broadly aligned, the next formal interaction is usually Scientific Advice, a procedure through which the EMA or national authorities provide a written, binding opinion on specific questions related to quality, nonclinical data, and clinical development.
If the product addresses a serious unmet medical need and may qualify for enhanced support, PRIME designation is worth exploring. PRIME, which stands for PRIority MEdicines, provides dedicated EMA support, early dialogue at the Committee for Medicinal Products for Human Use (CHMP), and accelerated review timelines for products likely to address conditions with no satisfactory treatment options. The ITF is a natural precursor: it helps developers understand whether their product is likely to qualify before investing in a formal PRIME application.
Once the clinical development plan is finalized, Clinical Trial Applications for EU trials are submitted through the Clinical Trials Information System (CTIS), the EU’s centralized platform for trial authorization since January 2022. Marketing Authorization is the final step, the formal application for approval to place the product on the EU market.
Can medical device and IVD developers request an ITF meeting?
The ITF is available to device and IVD developers when the product raises genuine classification questions. Drug-device combinations, companion diagnostics, AI-driven diagnostic tools, and borderline products where jurisdiction between the EMA and national competent authorities is unclear are all appropriate candidates. If your product has a straightforward MDR classification, your national competent authority or a notified body is the right starting point. The ITF becomes relevant when the classification itself is what needs resolving.
Does requesting an ITF meeting commit us to any regulatory position or timeline?
No. Requesting a meeting does not initiate a regulatory procedure, trigger any formal timeline, or constitute a regulatory submission. The discussion is not legally binding on either side.
How long does it take to get to an ITF meeting after submitting a request?
The EMA reviews the briefing package within one to three weeks and confirms whether a meeting is granted. If it is, available dates are provided within four to seven weeks.
Can a company outside the EU use the ITF?
Yes. Non-EU companies can access the ITF through regulatory consultancy, a specific access route for companies incorporated outside the European Economic Area who wish to develop products for the EU market. The EMA SME Office can advise on eligibility.
Do we qualify as an SME under the EMA’s definition?
The EMA defines an SME as a company with fewer than 250 employees and either annual revenue below 50 million euros or an annual balance sheet below 43 million euros. Meeting any one of these criteria is sufficient to qualify. SME status is confirmed through the EMA SME Office. For SMEs working on orphan medicines, fee waivers can reach 100% across formal procedures including Scientific Advice and Marketing Authorization applications.
What is the difference between the ITF and Scientific Advice?
The ITF is informal, free, and designed for early-stage products where regulatory classification or pathway is uncertain. Scientific Advice is a formal procedure that produces a written, binding regulatory position on specific questions related to quality, nonclinical, or clinical development. It requires a more developed data package and involves fees, which are reduced for SMEs. The ITF typically precedes Scientific Advice.
Is the ITF relevant for products targeting orphan diseases?
Yes. Orphan medicines are one of the product categories for which the ITF was originally designed. SMEs working on orphan products can also benefit from 100% fee waivers across many EMA procedures.
How much data do we need before requesting an ITF meeting?
You do not need a complete nonclinical or clinical data package. What is required is a focused briefing document: a concise product description, the therapeutic area or device application you are targeting, the specific regulatory uncertainties you need to resolve, and a brief summary of your current development stage.
Is there a limit to how many questions we can bring?
There is no published limit, but the one-to-one-and-a-half-hour format is a practical constraint. Developers who arrive with ten broad questions will get less useful output than those who arrive with three to five focused, specific ones.
What should a briefing package include?
A concise description of the product and its mechanism, the therapeutic area or device application you intend to address, the specific regulatory uncertainties you need to resolve, and a brief summary of your current development stage. A complete nonclinical or clinical data package is not required at this stage.
References
[1] European Medicines Agency. LinkedIn Live Session: How EMA Supports Innovators and Innovation in the EU Pharmaceutical Development Field. Moderated by Aleandro Faya; guest speaker Emmanuel Cormier, Head of Regulatory Science and Innovation Task Force. EMA Communications, 2025. Available at: https://youtu.be/8C5DVGGQH-k
[2] European Medicines Agency. Innovation Task Force (ITF) briefing meetings. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/innovation-task-force-briefing-meetings
[3] European Medicines Agency. Support for small and medium-sized enterprises (SMEs). Available at: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/support-small-and-medium-sized-enterprises-smes
[4] European Medicines Agency. PRIME scheme. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines
About the Author
PD Dr. Ghazaleh Gouya-Lechner is the founder of Gouya Insights and a cardiologist with over 20 years of hands-on clinical practice. She has worked across clinical development, regulatory strategy, and pharmacovigilance for both pharmaceutical and medical device companies. In 2017 she founded Gouya Insights, a CRO supporting early-stage biotech and medtech companies through clinical trials and drug development.
Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials
