Primary source: EMA - What's new RSS
Sign in with your work email to save this update, triage it, and track follow-up.
Sign in to saveThe INS-GCP-1 guidance has been updated to reflect new requirements and processes for GCP inspections, including the designation of inspectorates and roles of the reporting inspector.
This updated guidance affects all Marketing Authorization Holders (MAHs) and sponsors in the EU, highlighting important changes to GCP inspection coordination, which ensure compliance with quality and safety standards.
Sign in to unlock the full action card and owner assignment.
Sign in with your work email to read the full operational brief, action card, and evidence ledger.
Sign in with your work email to unlock the full briefing, regulatory action card, evidence ledger, and role-specific next steps.
PV teams should update workflows and SOPs to include the new section 19A approval processes and ensure compliance with the TGA's guidelines for managing medicine shortages.
PV teams should review and update their Standard Operating Procedures (SOPs) related to real-world data collection methodologies and ensure alignment with the new guidance emerging from the workshop. Training may also be required to enhance understanding of RWD's impact on regulatory submissions.
PV teams should update their regulatory intelligence monitoring workflows to include the timelines and requirements established by the EMA for thalassaemia treatments. It's essential to ensure adherence to the new guidelines in clinical trial designs.
Update workflows related to regulatory intelligence monitoring and ensure that all relevant SOPs reflect the new guidelines on clinical requirements for sickle cell disease treatments.
