Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Ensure all sites listed in marketing authorization applications are ready for inspection upon submission, and adhere to the new timelines for inspection requests and report submissions.

Regulatory Intelligence teams must initiate checks to monitor compliance and management of this recall, ensuring affected lots are removed from distribution.

Monitor the supply chain developments and prepare to adjust inventory management practices as the end of the shortage approaches.

Monitor for changes in labeling requirements and risk management strategies as a result of the ongoing review by PRAC.

Signal management teams need to prepare for potential updates in labeling, usage guidelines, and monitoring requirements for injectable iron-containing medicines.

Regulatory compliance workflows involving the Dengue Tetravalent Vaccine outside the EU need to incorporate the EMA's positive opinion concerning its use in individuals aged 4 to 60.

Regulatory intelligence processes must update reporting timelines and workflows to incorporate the new PSUSA findings for exemestane.

MAHs of products containing phenobarbital must monitor new cases of AHS and submit yearly updates to IRIS. The annual statement submission deadline is set for the end of November each year.