EMA

Marketing authorization holders must transition to the updated PLM Portal eAF by the mandatory deadline of September 1, 2026, ensuring correct submission of variations, particularly those related to pharmacovigilance.

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 Affairs teams must review the proposed data requirements and prepare for more rigorous documentation in registration applications and post-market monitoring.

Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.

MAHs and technical teams must review the revised API registration requirements and implement necessary system updates to comply by the established timelines.

Manufacturers must verify that their products meet the newly established acceptable intake levels for nitrosamines and implement necessary quality control measures to keep impurities within limits.

Update product information and guidance for use in elderly populations for Ixchiq; ensure compliance with PRAC recommendations.

Ema update requires triage for Local Affiliate Compliance, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

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.

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 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.

Sponsors must prepare for training on the new module and transition to its use for ASR submissions while ensuring all trial authorizations align with the timeline.

Regulatory intelligence should be updated to reflect the new PSUSA, and signal management processes may require reviews based on new safety information.

Ensure that all labeling and safety information reflects the updated product name 'Prasugrel Viatris' instead of 'Prasugrel Mylan'.

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.

MAHs must allocate resources to develop and maintain SPPs, ensuring they meet the new regulatory requirements and are ready for submission within two days upon request in crisis situations.

Implement the updated product information by November 5, 2026, ensuring that all labeling and documentation includes the new warnings and risk profiles.

The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.

Veterinary practitioners must now adjust their prescribing practices in accordance with the AMEG guidelines and monitor compliance with the new restrictions as outlined in the EMA's directive.

Annual reviews of new information will be conducted to update the summary, requiring continuous monitoring and data submission in response to findings.

Regulatory Intelligence teams must monitor updates regarding the ongoing CHMP evaluation and potential implications for existing marketing authorizations.

Sponsors and MAHs must review and align safety data collection and reporting protocols with the newly adopted guidelines while preparing for implementation of PRAC recommendations stemming from this meeting.

Regulatory Intelligence Leads must incorporate the new reporting requirements and deadlines into their monitoring activities for affected products.