Recording available: Webinar on navigating the EU regulatory pathway for ATMPs with EMA guidance

Brussels, July 17th 2026

Summary

›The EIC Portfolio on Cell and Gene Therapy and the European Medicines Agency ran a training webinar on 21 May 2026 about the EU regulatory pathway for Advanced Therapy Medicinal Products.
›Patrick Celis from EMA explained key regulatory milestones for cell and gene therapies, and practical support routes available from EMA for early-stage developers.
›The session recording is now available through the EIC Community, and the webinar is part of a broader EIC-EMA cooperation to support health innovators in Europe.
›Early regulatory engagement is emphasised, but developers should be aware that regulatory interactions do not remove technical, manufacturing and financial challenges.

Recording available: Navigating the EU regulatory pathway for ATMPs

A training webinar on how to navigate the European regulatory pathway for Advanced Therapy Medicinal Products took place on 21 May 2026. The event was organised by the European Innovation Council Portfolio on Cell and Gene Therapy together with the European Medicines Agency. It targeted developers including small and medium sized enterprises and academic teams. The session recording is now available through the EIC Community platform.

Who presented and what the session aimed to achieve

Patrick Celis, Lead Scientific Officer in EMA’s Office of Advanced Therapies and Haemato-oncology and Scientific Lead to the Committee for Advanced Therapies, led the webinar. The session set out to give innovators a clearer picture of the regulatory route for cell and gene therapies in the EU, with a focus on early stage considerations, practical support mechanisms at the EMA and opportunities for early interactions with regulators.

What developers heard and why it matters

The webinar covered the sequence of regulatory steps developers can expect when advancing an ATMP from discovery towards clinical development and authorisation. It highlighted the types of scientific and regulatory advice available, regulatory classification processes, expectations on quality and manufacturing, and clinical development considerations that are specific to cell and gene therapies. The session also signalled the EIC’s role in connecting innovators with regulatory expertise and forming part of an extended cooperation between EIC and EMA to support Europe’s health innovators.

Key messages for innovators

Early regulatory engagement is essential:EMA and national regulators can advise on product classification, nonclinical packages, clinical trial design and manufacturing controls. Early dialogue reduces uncertainty, helps prioritise data generation and can prevent costly redirection later in development.

Regulatory support does not mean the pathway is simple:Interactions with regulators provide clarity but they do not shorten the inherent technical challenges. Developers must still demonstrate robust potency assays, consistent manufacturing under GMP, and clinical benefit, which are often resource intensive and time consuming.

Use the right EMA mechanisms at the right time:EMA offers a range of tools from early informal engagement to formal scientific advice. Choosing the correct mechanism and the right timing adds value but requires an informed regulatory strategy.

EMA support mechanisms in practice

The webinar described several specific routes for engagement and support at the EMA. Below is a practical table that summarises common mechanisms, what they are intended to achieve and when developers typically use them.

Mechanism	What it does	When to use it
Innovation Task Force (ITF)	Early, informal dialogue to discuss an emerging technology and identify regulatory questions and likely data needs	Very early, before full nonclinical or manufacturing packages are ready
ATMP classification	Formal determination whether a product falls under the ATMP regulatory framework, which affects the route of assessment	As soon as the product concept is defined or when there is doubt on classification
Scientific Advice	Formal advice on specific development plans, nonclinical models, clinical trial design and quality expectations	Prior to pivotal trials or before committing substantial resources to a specific development plan
Protocol Assistance for orphan products	A form of scientific advice tailored to orphan designation and associated incentives	When seeking orphan designation and planning pivotal studies
Certification (for SMEs and applicants to early stage funding)	Assessment of quality and nonclinical data to support development and funding decisions	When preparing for scaling up development or applying for support schemes
PRIME or other accelerated pathways	Enhanced support for promising therapies that address unmet medical needs, aiming to accelerate development and review	When preliminary clinical data show strong potential for major therapeutic benefit
Centralised marketing authorisation via EMA	Single EU authorisation procedure for ATMPs that results in an EU wide marketing authorisation	At marketing authorisation stage for products intended for wider EU patient access

Specific regulatory and technical considerations for ATMPs

Manufacturing and quality control:ATMP developers must demonstrate consistent manufacturing under Good Manufacturing Practice, robust potency assays, product characterisation and comparability across batches. These demands often drive the largest technical and budgetary effort.

Nonclinical models and safety assessment:Classical toxicology packages may not be fully applicable. Developers should discuss appropriate nonclinical models and risk mitigation strategies with regulators early.

Clinical development and endpoints:Choice of clinical endpoints, patient selection, long term follow up and the design of trials in small populations are recurrently challenging for cell and gene therapies. Regulators expect a rationale for chosen endpoints and monitoring plans.

How this webinar fits into the wider EIC and EU support landscape

The webinar is part of an ongoing cooperation between the European Innovation Council and the European Medicines Agency. The wider collaboration seeks to raise regulatory awareness among innovators and to provide training, advice and horizon scanning to map emerging technologies. Separately, EMA and the European Innovation Council and SMEs Executive Agency signed a Letter of Intent in July 2026 to deepen cooperation, with a focus on earlier regulatory support for SMEs and on helping innovators understand development pathways.

Evidence of impact so far:A survey cited by EISMEA and EMA found that around three quarters of EIC funded innovators increased their awareness of EMA regulatory support tools after joint training activities. Respondents reported positive effects on development plans and regulatory strategy and strong willingness to use the tools again. EIC programme staff also highlighted concrete cases where early regulatory contact helped companies choose an appropriate pathway.

Illustrative example:EIC backed company Ebenbuild, which works on a digital twin approach for lung disease, benefited from early exchanges with EMA to better understand regulatory expectations and to identify a development route. Such examples show how targeted interactions can shape strategy but they do not remove the technical and commercial risks that remain.

What the webinar recording is and is not

The recording is a training and information session aimed at improving understanding of EU regulatory processes. It is not a substitute for formal regulatory procedures or legal advice. Developers who intend to act on regulatory advice should follow up through official EMA channels and, where necessary, seek qualified regulatory or legal counsel. The original EIC post includes a standard disclaimer that the content is for knowledge sharing and does not represent the official view of the European Commission or other organisations.

Practical next steps for ATMP developers

Watch the recording:The webinar replay is available on the EIC Community platform. Developers should review the session to identify which EMA mechanisms match their development stage.

Prepare for early interaction:Compile data on product concept, manufacturing approach and key preclinical findings. Even at an early stage, a clear description of the intended patient population and proposed mode of action helps regulators give more useful feedback.

Use EIC Business Acceleration Services where appropriate:EIC offers coaching, regulatory support services in its catalogue and programmes that can help with strategy and investor readiness. These services can be complementary to EMA interactions but they will not replace formal regulatory advice.

A candid note for readers

Joint training by EIC and EMA is useful and it improves awareness among innovators. However, training alone does not resolve core technical bottlenecks in ATMP development. The most common practical obstacles remain scalable GMP manufacturing, validated potency assays, long term safety monitoring and securing sufficient funding to complete development. Early regulatory dialogue reduces avoidable mistakes but it does not eliminate the need for careful scientific, clinical and manufacturing work and for realistic business planning.

Further information

For the webinar recording and associated materials visit the EIC Community news entry titled "Recording now available: 'Navigating the EU Regulatory Pathway for Advanced Therapy Medicinal Products (ATMPs)' webinar". For formal regulatory procedures and submissions consult the European Medicines Agency website and the Committee for Advanced Therapies guidance pages. The EIC Business Acceleration Services and the EIC Service Catalogue list available support services for innovators seeking regulatory and commercial assistance.

About the European Medicines Agency. The EMA is the decentralised EU agency responsible for the scientific evaluation, supervision and safety monitoring of medicines for human and veterinary use. Based in Amsterdam, EMA aims to protect and promote public and animal health by assessing that medicines available on the EU market are safe, effective and of high quality.

Disclaimer. The webinar and this article are for information and training. They should not be interpreted as official legal or regulatory advice from the European Commission or other bodies. Developers should use official EMA procedures for formal interactions.

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