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ShareThe European Medicines Agency (EMA) announced a new Voluntary Data Submission (VDS) pilot program designed to advance the use of New Approach Methodologies (NAMs) in the development of medicines.
Companies, method developers, contract research organisations, academic laboratories, and other stakeholders can voluntarily submit data from these approaches used in the development of medicines and receive tailored, non-binding feedback from regulators independent of applying for market authorisation.
The EMA will accept data falling within four “Regulatory Applicability Areas” (RAA):
- RAA 1: Risk assessment of biologics with no pharmacologically relevant species or biologics with partial response in non-clinical test species
- RAA 2: Developmental and reproductive toxicity (DART) Risk Assessment in Accordance with ICH S5(R3)
- RAA 3: Safety pharmacology
- RAA 4: Hepatotoxicity and drug-induced liver injury (DILI) prediction
The pilot aims to bridge a widening gap between the expanding use of NAMs and regulators’ experience evaluating their data and incorporating them into regulatory decision-making. The program also aims to support scientific dialogue between developers and regulators, confidence in and harmonisation of non-animal approaches across Europe, and a sustainable framework for integrating non-animal approaches into medicines regulation.
Stakeholders can submit applications to participate in the pilot through the third quarter of 2027, after which the EMA will publish a lessons-learned report.
Click here for more information.