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A selection of European Commission activities for the advancement of

New Approach Methodologies (NAMs)

Giulia Leonetti– Policy Officer, Health Innovations and Ecosystems

DG RTD

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Content

The European Biotech Act

The ERA Action on NAMs

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The European Biotech Act at a glance

Timeline

Commission proposal adopted on 16 December 2025

Goal

�Boost innovation,

support development of biotech products,

accelerate time-to-market

Overall structure

1) Industrial enablers 2) regulatory simplification (regulation + directive)

Scope

�Focus on health biotech, (representing 81% of biotech sector), food biotech, enabling biotech (GMM)

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Policy context

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Focus areas of the European Biotech Act

Food and �other Biotech

Enhance EFSA’s role to provide scientific pre-submission advice to companies
Regulatory sandboxes
Ensure appropriate treatment of genetically modified microorganisms (GMMs)

Health Biotech

Make the authorisation procedure for clinical trials, including multinational, faster, simpler and more predictable
Regulatory facilitation for borderline and combination products

Access to Finance

De-risk private investment into Biotech with the EIB Group, with a pilot to be reviewed after 2 years + project mobilising €10bn over the next 2 years

(High Impact) �Strategic Projects

Strategic projects at MS or EU-level including to:

Boost biomanufacturing capacity
Enhance biotech skills
Connect biotech clusters across Europe

Boost Innovative �Biotech + Biosimilars

Incentivise the development of innovative biotech medicines with 1 year of extra IP protection
Enhance competitiveness in biosimilars through dedicated support

Biosecurity & Biodefence

Guard against misuse of biotech with a screening framework while boosting biodefence capacity

AI and data:

Accelerate AI-enabled innovation throughout the health biotech lifecycle with improved access to quality data, testing environments and guidelines

Industrial enablers

Regulatory streamlining and facilitation (time-to-market)

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Industrial policy enablers:�(High impact) health biotech strategic projects

Strategic projects focus action on priority initiatives based on EU criteria. They contribute to the Union’s biotechnology objectives, by strengthening industrial capacity and value chains, scaling up critical research and technology infrastructures, accelerating innovation and technology deployment
(one of the) Specific objectives: promoting and integrating the use of NAMs in areas such as biological research, discovery and preclinical development, regulatory and quality testing and production of medicinal products and medical technologies

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Industrial policy enablers:�(High impact) health biotech strategic projects

Strategic mapping of EU Biotech ecosystem

EU Health biotech support network

EU Health Biotech Steering Group

Strategic steering

Support

Strategic projects: instruments to focus action on priority initiatives

Recognition at MS-level, based on

EU-level criteria:

-Industrial capacity

- value chains

-Critical infrastructures

-Innovation

-Skills

-Preparedness

High impact strategic projects

Systemic and catalytic potential for the EU biotech ecosystem

Recognition at EU-level

Access to risk-tolerant capital through the EU Biotechnology Investment Pilot

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The ERA Action on NAMs

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European Research Area (ERA) action on NAMs

Aim: Coordinate and streamline Member States’ and other stakeholders’ actions on NAMs

Focus on biomedical research and regulatory testing of medicinal products and medical devices

All actors involved: European Commission, relevant ministries, regulatory agencies, EMA, research funders, academia, research institutes & infrastructures, pharma and MedTech industry, CROs, journal editors, NGOs, citizens & patients

Holistic approach involving all stages of biomedical research—from the basic discovery phase to application, implementation, and regulatory testing of medicinal products and medical devices

Targets ~80% of animal use in EU

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NAM ERA structure

WG1: Development of NAMs and common EU infrastructures

WG2: Validation, acceptance and implementation of NAMs

WG3: Education and training

WG4: Openness & awareness

3 years: Q4 2025-Q4 2028

18 Member States + 5 ACs

>200 experts from public & private sector