EMA Defines an Expert Group’s Role in Assessing NAMs Data
The NAMs Operational Expert Group will review proposed uses of NAMs, support consistent assessment across the European regulatory network and contribute to EMA’s voluntary data-submission pilot.
- Issuing Authority
- European Medicines Agency
- Jurisdiction
- European Union
- Document Covered
- Official New Approach Methodologies Operational Expert Group webpage, including its listed provisional mandate EMA/136020/2026, first published 6 October 2026.
A Shared Forum for Scientific Assessment
EMA has published the provisional mandate for its New Approach Methodologies Operational Expert Group, with a first-publication date of 6 October 2026. The group supports the scientific and regulatory assessment of NAMs and their use in medicines-related decisions.
The group reports to the 3Rs Working Party and the Non-clinical Working Party, and informs the Committee for Medicinal Products for Human Use when needed. Its tasks include discussing submitted NAM data, proposed contexts of use and possible regulatory applications. It also examines scientific uncertainties and opportunities to incorporate those data into evidence-based assessments.
Connecting Data Submissions with Regulatory Learning
The expert group supports EMA’s Voluntary Data Submission pilot, which lets developers share NAM data outside a marketing-authorization application. It will discuss those submissions, provide feedback on their potential relevance and possible follow-up routes, and contribute to an aggregated lessons-learned report.
A second part of the mandate concerns knowledge sharing, training and consistent interpretation across the European medicines regulatory network. Committee nominations draw on European experts in nonclinical assessment, NAMs and weight-of-evidence approaches. This combination links the review of individual datasets with the development of shared assessment expertise.