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Browsing Tag

Guidance

7 posts

The new European Shortages Monitoring Platform becomes mandatory

The second version of the European Shortages Monitoring Platform, to be launched on 2 February 2025, will include all functionalities to report shortage issues on a routine basis or concerning preparedness exercises or declaration of a health crisis. All the guidance needed to manage the reporting, as well as the drafting of the Shortage Prevention Plans and Shortage Mitigation Plans, is available on the EMA website

EMA’s recommendations to prevent medicines shortages

By Giuliana Miglierini Continuity of medicinal product supply is still representing a key issue for European countries. The…

EDQM introduces a consultation phase in the management of CEP documents

by Giuliana Miglierini The new process implemented by the European Directorate for the Quality of Medicines and HealthCare…

MDCG, a position paper on the capacity of notified bodies

by Giuliana Miglierini The lack of a suitable capacity of notified bodies (NBs) is one of the main…

Real-world evidence for regulatory decision-making

by Giuliana Miglierini Digitalisation is rapidly advancing also in the regulatory field, as a tool to improve the…

Joint implementation plan for the IVDR regulation

by Giuliana Miglierini Regulation (EU) 2017/746 (IVDR), establishing the new legislative framework for in vitro diagnostic medical devices…
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