Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Stakeholders must express interest in the pilot by submitting an application form prior to the full submission of data, with the pilot set to run through 2027.

Manufacturers must now incorporate expert panel feedback into their conformity assessment processes, ensuring timely integration of provided expert advice into their evaluation and regulatory submissions.

Update local protocols to ensure parenteral nutrition is administered with filters in compliance with the new requirements.

Healthcare facilities must initiate the removal process for affected lots, isolate impacted products, and communicate the recall information to all relevant healthcare professionals. Compliance with the outlined return process is mandatory.

Pharmacies within healthcare establishments must review the safety information and adhere to the guidance issued by ANSM regarding the usage of the device.

Surgifrance must implement corrective actions, including the establishment of processes for handling complaints in 3 months, and a complaints register within 8 months.

Pharmacovigilance systems must be updated to monitor and report on the newly added medications.

Focus on therapeutic equivalence evaluations for generics