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MAHs and sponsors must register for an EMA account and appropriate role to submit via the IRIS platform, as this is a new requirement for all IRIS submissions.

Organizations must establish an active EMA user account, ensure they have a valid EMA customer account number, and complete the SPOR/OMS registration process within five to ten working days if not previously registered.

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.

Immediate compliance is necessary for MAHs to implement SPPs, including documenting production and supply capacities and establishing internal collaborative processes across supply chain, regulatory, and pharmacovigilance teams.

Pharmaceutical companies wishing to participate in the pilot must submit the same documentation to all involved national authorities, thus standardizing the submission process.

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

MAHs must prepare for updated risk management plans and post-marketing surveillance processes, reflecting the revised data requirements and definitions for biosimilars as per the NPL.

Implement increased documentation and reporting processes for traditional herbal medicinal products. Ensure staff receive training on the complexities involved in signal management for these products.

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.

MAHs should verify their product's status on the additional monitoring list and ensure compliance with labeling requirements for any additions or removals during their next regulatory submission.

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.

Clinical trial sponsors must update internal standard operating procedures (SOPs), conduct staff training on the functionality of the new ASR module, and utilize the CTIS training environment to ensure readiness for compliance with the new workflow.

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 update SOPs related to DDI study design and regulatory compliance to align with the ICH M12 guidelines. Additionally, workflows regarding gastrointestinal interactions will need revision following forthcoming guidelines addressing these gaps.

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 Intelligence teams should monitor the outcomes of these consultations and update relevant standard operating procedures (SOPs) regarding data governance and reporting, ensuring compliance with new guidelines post-consultation.