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The EMA will publish detailed reporting in Excel format starting March 2025, covering extension applications and type II variations to authorized indications.
This change enhances the transparency and accessibility of information regarding new human medicines under evaluation, facilitating better regulatory planning and compliance monitoring.
Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.
Beginning March 2025, the European Medicines Agency (EMA) will provide monthly updates in Excel format regarding medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). This will include information on the start of procedures for extension applications and type II variations proposing extensions of authorized indications, aiding in data analysis and regulatory transparency.
What changed: The EMA will publish detailed reporting in Excel format starting March 2025, covering extension applications and type II variations to authorized indications.
Why it matters: This change enhances the transparency and accessibility of information regarding new human medicines under evaluation, facilitating better regulatory planning and compliance monitoring.
Practical implication: Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.
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