# Ne oldu?

The European Medicines Agency (EMA) has launched a new voluntary data submission (VDS) pilot. This pilot aims to collect and evaluate data generated through New Approach Methodologies (NAMs) — including organoids, microphysiological systems, and computational models. Who is involved? EMA and an operational expert group of non-clinical experts from across the European medicines regulatory network. What happens? Participants submit their NAM data, and an expert group provides individual, non-binding and non-decisional feedback. The process is independent of marketing authorization applications.

# Ayrıntılar

The pilot program encompasses NAM technologies such as organoid cultures, microphysiological systems (organ‑on‑a‑chip), and various computational models. Participants submit experimental results, methodological descriptions, and potential risk assessments generated using these methods. Feedback is prepared by an operational expert group of non-clinical experts; the group includes experts from different units of the European medicines regulatory network. The feedback is non-binding and non-decisional in nature; meaning that rather than a definitive regulatory decision, guiding recommendations are provided to assist the development process. The program offers a framework independent of marketing authorization applications, allowing developers to improve their methodologies at early stages.

# Neden önemli?

This pilot is seen as a critical step for advancing the recognition of alternatives to traditional non-clinical testing within the regulatory environment. According to EMA’s explanation, NAMs can provide information comparable to, or better than, current testing approaches and have the potential to reduce or replace animal use in the non-clinical development of medicines. Directly contributing to the 3Rs principle is both an ethical and scientific milestone. Furthermore, allowing developers to receive expert feedback early in the process can save time and resources, increasing the efficiency of the drug development pipeline. The pilot also establishes a data-driven foundation for shaping future regulatory guidance and policy.

# Sırada ne var?

The pilot process is currently ongoing; EMA will conduct a comprehensive evaluation of the data packages received. Evaluation results can be used to shape future regulatory guidance and policies. Participants’ feedback provides a roadmap for improving their methodologies and mapping potential regulatory acceptance pathways. EMA plans to share the pilot’s outcomes with the public and develop recommendations for integrating this experience into regulatory frameworks. The progress of the pilot and the findings obtained can further clarify the role of NAMs in the drug development process and pave the way for the wider adoption of alternatives to animal testing.