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This content applies to human and veterinary medicines.
The pilot seeks to enable stakeholders to submit and discuss new approach methodologies (NAMs) data in a voluntary manner, outside marketing authorisation applications.
Stakeholders include companies, method developers, contract research organisations and academic laboratories.
The pilot is part of EMA's efforts to:
EMA launched its voluntary data submission pilot in September 2026.
For more information on new approach methodologies, see:
The voluntary data submission pilot addresses the lack of received data on new approach methodologies (NAMs).
Although NAMs are increasingly used in research and early medicine development, regulators receive related data rarely. This limits opportunities to build confidence in their regulatory application.
The pilot aims to resolve this challenge by decoupling NAM data submission from the product authorisation process. This allows stakeholders to submit these data without concern that the assessment could delay or negatively affect a marketing authorisation application.
EMA provides pilot participants with independent, non-binding feedback on the regulatory readiness of their NAM.
This feedback comes together with advice on appropriate next steps, such as engagement through EMA's Innovation Task Force (ITF), scientific advice or qualification advice.
The feedback and advice are intended to accelerate both the qualification and regulatory acceptance of NAMs. They are also meant to help developers prepare for future inclusion of NAMs as part of clinical trials and marketing authorisation applications.
EMA plans to publish a lessons learned report upon completion of this pilot.
For more information on EMA's initiatives to support innovation and provide scientific advice, see:
EMA invites stakeholders interested in participating in the pilot to submit an application, using the form provided below.
Submit completed forms to VDS@ema.europa.eu.
The form includes information on the pilot's eligibility and limited scope - in terms of predefined contexts of use and regulatory applicability areas.
In the next steps, EMA validates the applications within the scope of the pilot. It then invites eligible applicants to submit a full briefing package for scientific assessment.
A pilot information document is also available below, covering:
Applications are expected to remain open until September 2027.
For any queries, please contact EMA via the email address above.
EMA processes all personal data received in pilot applications in accordance with Regulation (EU) 2018/1725 on the protection of individuals regarding the processing of personal data by the Union Institutions and bodies on the free movement of such data.
If you have any questions, complaints or concerns about the processing of your personal data, you can contact EMA’s Data Protection Officer at dataprotection@ema.europa.eu.
You can also contact EMA's Internal Controller at datacontroller.humanmedicines@ema.europa.eu.
In addition, if needed, you may lodge a complaint with the European Data Protection Supervisor: edps@edps.europa.eu.
EMA assesses and publishes the outcome of the pilot respecting commercially confidential information.
For more information on data protection at EMA, see:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in September 2026.
1 September 2026
Page first published