New Approach Methodologies (NAMs) are innovative methods, such as in vitro systems, computational models, and combined methodologies, aimed at progressively replacing, reducing, and refining (‘3Rs’ principles) traditional animal studies. These methods hold the potential to provide data comparable to, or even more reliable than, current testing approaches.
In line with these principles, the European Medicines Agency (EMA) has launched a new Voluntary Data Submission (VDS) pilot for companies, contract research organisations, methodologists, and other stakeholders to facilitate the sharing of data generated using NAMs.
This pilot represents another step in the EMA’s efforts to promote the regulatory acceptance of NAMs across the European Union (EU). To support developers, the EMA offers several regulatory interactions:
- Briefing meetings within the EMA’s Innovation Task Force (ITF) on NAM development and readiness;
- Scientific Advice to address specific scientific and regulatory questions;
- Qualification procedures through the Committee for Medicinal Products for Human Use (CHMP).
Additionally, the EMA has released two dedicated guidelines outlining key considerations for the regulatory acceptance of NAMs to assist developers with these interactions. Additional information can be found here.
The VDS pilot aims to enhance scientific dialogue, build regulatory experience with NAMs, promote harmonised assessment approaches across Europe, and support the development of a sustainable framework for integrating these innovative methods into medicines regulation. Submissions and discussions under this pilot take place independently of marketing authorisation applications. Participants will receive tailored, non-binding, and non-decisional feedback from an operational expert group of non-clinical experts across the European medicines regulatory network.
For more information, visit the official EMA page: Voluntary data submission pilot to advance innovative alternatives to animal testing | European Medicines Agency (EMA)
