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A voluntary data submission pilot has been initiated, enabling stakeholders to submit NAMs data for consideration independent of existing regulatory procedures.
This initiative promotes the use of innovative testing methodologies, potentially leading to reduced reliance on animal testing and more efficient regulatory decision-making.
Stakeholders can submit NAMs data by completing the prescribed application form, available until Q3 2027.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Stakeholders can submit NAMs data by completing the prescribed application form, available until Q3 2027.
The EMA's new pilot allows stakeholders to submit NAM data for tailored feedback, aiming to facilitate innovative alternatives to traditional animal testing.
What changed: A voluntary data submission pilot has been initiated, enabling stakeholders to submit NAMs data for consideration independent of existing regulatory procedures.
Why it matters: This initiative promotes the use of innovative testing methodologies, potentially leading to reduced reliance on animal testing and more efficient regulatory decision-making.
Practical implication: Stakeholders can submit NAMs data by completing the prescribed application form, available until Q3 2027.
Published from the regulator source ingestion pipeline after PV impact triage.
Ensure that all labeling and safety information reflects the updated product name 'Prasugrel Viatris' instead of 'Prasugrel Mylan'.
The program will implement collaborative processes for the evaluation of technologies, enhancing real-world evidence integration into signal management and impacting regulatory compliance workflows.
Operational support will now be increased for disease surveillance, health worker assistance, and community outreach based on the new funding and response framework.
Enhanced monitoring for products with hidden drug ingredients is required, leading to increased need for rapid reporting and investigation of adverse events associated with similar products.
