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A revised model for pre-submission interactions is now being piloted. This includes structured timelines for application submissions, with specific advance notice requirements for requesting rapporteurs and the submission of key documents.
This pilot offers a new approach to regulatory interactions that could lead to smoother application assessments, potentially decreasing delays and improving submission quality for future marketing authorisation applications.
Applicants must adhere to new timelines: submit a rapporteurs' allocation request 9 months prior to the intended MAA submission date, and submit their Letter of Intent at least 2 months before the MAA submission.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Applicants must adhere to new timelines: submit a rapporteurs' allocation request 9 months prior to the intended MAA submission date, and submit their Letter of Intent at least 2 months before the MAA submission.
The EMA is undertaking a pilot that will introduce a revised framework for pre-submission interactions with the aim of optimizing submission readiness and reducing the occurrence of ‘premature’ applications. The pilot will enhance communication between applicants and the EMA, involving structured timelines and responsibilities in the marketing authorisation application process.
What changed: A revised model for pre-submission interactions is now being piloted. This includes structured timelines for application submissions, with specific advance notice requirements for requesting rapporteurs and the submission of key documents.
Why it matters: This pilot offers a new approach to regulatory interactions that could lead to smoother application assessments, potentially decreasing delays and improving submission quality for future marketing authorisation applications.
Practical implication: Applicants must adhere to new timelines: submit a rapporteurs' allocation request 9 months prior to the intended MAA submission date, and submit their Letter of Intent at least 2 months before the MAA submission.
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.
