The EURD list has been updated, affecting the submission timelines for PSURs for various medicinal products authorized in the EU.
Failure to adhere to the revised PSUR submission frequencies can result in regulatory actions against Marketing Authorisation Holders (MAHs), emphasizing the need for timely updates to submission calendars.
Marketing Authorisation Holders (MAHs) must update their global submission calendars in accordance with the new EURD submission frequencies and ensure compliance with the updated requirements to avoid regulatory consequences.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Marketing Authorisation Holders (MAHs) must review the updated EURD list to identify changes to data lock points or submission frequencies for their products. PV operations teams should update their global submission calendars to ensure compliance with the new deadlines, as failure to submit PSURs according to the EURD frequency can lead to regulatory action. No specific SOP changes are mentioned, but calendar updates are mandatory.
Increases compliance requirements and modifies existing submission processes for all MAHs.
Mandatory PSUR submissions must now be made using the PSUR Repository in eCTD format.
Marketing Authorisation Holders (MAHs) must update their global submission calendars in accordance with the new EURD submission frequencies and ensure compliance with the updated requirements to avoid regulatory consequences.
The European Medicines Agency has updated the EURD list, defining new data lock points and submission frequencies for Periodic Safety Update Reports (PSURs) within the EU. Marketing Authorisation Holders (MAHs) are required to carefully review the updated list for any changes that may affect their products. Compliance with the new submission deadlines is essential to avoid regulatory repercussions.
What changed: The EURD list has been updated, affecting the submission timelines for PSURs for various medicinal products authorized in the EU.
Why it matters: Failure to adhere to the revised PSUR submission frequencies can result in regulatory actions against Marketing Authorisation Holders (MAHs), emphasizing the need for timely updates to submission calendars.
Practical implication: Marketing Authorisation Holders (MAHs) must update their global submission calendars in accordance with the new EURD submission frequencies and ensure compliance with the updated requirements to avoid regulatory consequences.
Published from the Firecrawl policy change extraction pipeline.
Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.
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