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.

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

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.

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.

PV teams should prepare to review and update relevant SOPs and workflows to incorporate feedback mechanisms and timelines associated with the new guidelines. Ensure monitoring of the consultation period and prepare for adjustments based on feedback.

PV teams need to update workflows and SOPs to incorporate the new PMS public API access protocols. This includes designing processes for monitoring user data access and ensuring compliance with the terms of use.

Regulatory teams must integrate the new guidelines into clinical development plans for migraine treatments, particularly focusing on designing studies that consider high placebo response rates in children and the new early intervention protocol.

The pharmacovigilance department must increase reporting obligations for any adverse effects related to Rezolsta as part of ongoing safety monitoring.

Stakeholders must review and update the labeling of Benlysta in accordance with the new indications highlighted in the EPAR.

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.

Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.

Review the PSUSA documents for calcifediol and ensure alignment with any PRAC recommendations if applicable.

Marketing authorisation holders should prepare to update their COVID-19 vaccines to target the XFG variant for the upcoming campaign; monitor for further regulatory guidance and prepare for potential strain change submissions.

Update internal systems and workflows to integrate monthly Excel reports from EMA starting March 2025, ensuring timely capture of information on medicines under evaluation and any extension applications.

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.

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.

PV teams should review and update Standard Operating Procedures (SOPs) to align with new EMA guidelines on data management, accessibility, and sharing. Ensure compliance with the security standards outlined by the EMA to protect sensitive data and maintain data integrity.

PV teams should update SOPs related to inspection readiness and regulatory intelligence monitoring to align with the new coordination steps and deadlines mandated in the INS-GCP-1 procedure.

Update workflows and SOPs to incorporate the new biowaiver criteria, particularly in regulatory filing processes for applications involving additional strengths of solid oral dosage forms.

PV teams need to update SOPs and workflows related to user safety risk assessments and ensure that procedures are aligned with the new draft guidelines prior to its implementation following the consultation.

Update workflows and SOPs related to Country Compliance and PMF submission processes to ensure timely response to the newly defined 60-day timelines.

Regulatory teams should update SOPs to reflect the new guidance on QT/QTc evaluations, ensure that all relevant personnel are trained on the updated methodologies, and incorporate the revised evaluations into ongoing and future study protocols.

PV teams must revise SOPs for inspection readiness to incorporate increased collaboration and risk-based planning protocols, ensuring that workflows align with the new inspection resource allocation strategies.

Review updated EMA guidance on mechanistic model reporting and qualification when published; align sponsor submissions with new qualification pathways and reporting requirements for MIDD and safety-related models.