New Approach Methodologies Operational Expert Group

The New Approach Methodologies Operational Expert Group (NAMs OEG) supports the scientific and regulatory evaluation of new approach methodologies. It strengthens NAM expertise and consistency across the European medicines regulatory network.

The operational expert group supports the scientific and regulatory evaluation of new approach methodologies (NAMs), and their use in regulatory decision-making.

The group contributes to the development of regulatory knowledge, consistency and expertise in NAMs across the European medicines regulatory network.

For more information on CHMP's working parties and other groups, see:

• CHMP: Working parties and other groups

Role

The group reports to the 3Rs Working Party (3RsWP) and the Non-clinical Working Party (NcWP). 

It also and informs the Committee for Medicinal Products for Human Use (CHMP), as needed.

The group carries out the following activities:

• Reviews and discusses NAM data, proposed contexts of use and potential regulatory applicability
• Identifies scientific and regulatory challenges, uncertainties and opportunities to integrate NAM data into evidence-based assessments
• Provides feedback on the potential relevance of submitted NAMs and possible regulatory follow-up pathways
• Promotes consistent interpretation and assessment of NAM data across the European medicines regulatory network
• Supports knowledge sharing and training to advance the development, validation and regulatory uptake of NAMs

The group supports EMA’s Voluntary Data Submission (VDS) pilot. This pilot enables developers to submit NAM data outside the context of a marketing authorisation application.

The group reviews and discusses these submissions and contributes to an aggregated lessons-learned report.

For more information, see:

• 3Rs Working Party
• Non-clinical Working Party 
• New approach methodologies to replace and reduce animal testing: Voluntary data submission pilot | European Medicines Agency (EMA)

Mandate and rules of procedure

Information on the group’s mandate, objectives and rules of procedure is available in the document below:

Provisional mandate, objectives and rules of procedure for the New Approach Methodologies Operational Experts Group (NAMs OEG)

Reference Number: EMA/136020/2026

Composition

EMA committee members nominate the members of the group from among European experts. They take into account the expertise needed to fulfil the group's tasks.

The non-clinical domain approves the group's membership and submits it to the CHMP for adoption.

Members bring expertise in non-clinical assessment, NAMs and weight-of-evidence approaches. This including their scientific basis, interpretation and potential regulatory use.

The current members are listed below, in alphabetical order of surname. Their declarations of interests are available in the European expert list.

Members

The current members are listed below, in alphabetical order of surname.

The members' declarations of interests are available in the European expert list.

• Roel Arends
• Sonja Beken
• Sonja Beken
• Hsiao-Tzu Chien
• Ann Detroyer
• Joren de Smet
• Karen de Smet
• Britt Duijndam
• Doris Höschele
• Pia Leineweber
• Solange Levison
• Alessandra Marabello
• Peter van Meer
• Xiaoyu Niu
• Jaana Palomaki
• Puck Roos
• Sara Tognarelli

Page update history

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The tracking of updates begins in October 2026.

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12 October

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