Regulatory intelligence in PV

Safety lead to: (1) perform a UK-clinical-trial safety reporting gap assessment against MHRA’s effective guidance sections (MedDRA coding; AE/SAE; RSI governance; SUSARs; annual safety reporting; USMs; serious breaches; temporary suspension), (2) update controlled SOPs/WIs and training records to reflect “effective” status as of 28 Apr 2026, and (3) document deviations/gaps and open CAPA where needed for ongoing UK trials and new submissions.

Suppliers must implement new protocols for safety reporting and record-keeping as per the proposed framework.

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.

Ensure all relevant teams are prepared to transition to the mandatory SEND format for data submissions by the effective date of 15 June 2026.

1) Verify your internal signal assessment narrative for GLP-1 RAs reflects FDA’s statement that the preliminary evaluation does not suggest a causal link; 2) Check whether any company-facing statements, FAQs, or labeling change proposals referencing suicidality need to be updated for consistency with FDA’s current public position; 3) Log the FDA update in regulatory intelligence tracking and maintain monitoring for further FDA conclusions or requests (including the linked 13 Jan 2026 communication).

1) Retrieve and review the updated “Submitting risk management plans guidance document” (PDF) and linked templates referenced from the overview (e.g., RMP note to reviewer, Canadian-specific addendum, RMP summary template) and map deltas vs the superseded 2015 approach. 2) Update Canada submission checklists/work instructions for the 1 July 2025 effective date, including the requirement that the RMP include a summary in English and French and use of the RMP summary attestation/acknowledgment form. 3) Ask Regulatory Intelligence/RA to brief PV leadership on the Agile Licensing notice timeline (RMP provisions in force 1 April 2027) and confirm how transitional provisions will be operationalized for existing RMPs submitted prior to that date.

Safety/Device Vigilance owner to: (1) confirm SOPs and training link to MHRA’s “Medical devices: post-market surveillance” collection as the live index; (2) validate operational readiness to submit adverse incident and FSCA-related reports via MHRA’s referenced MORE route; (3) confirm device PSUR process uses MHRA-linked standardised PSUR format and PSUR guidance tied to the Regulations 2024 framework; (4) update internal regulatory intelligence trackers with the 16 June 2025 in-force date cited across MHRA guidance, and monitor related MHRA future regime pages for further updates.

1) Inventory AI use cases that could feed regulated decisions (including PV/safety-related analyses or summaries used in regulatory interactions) and map owners/vendors. 2) For each AI use case, document context of use, intended outputs, and controls (e.g., review/approval, traceability, change management) aligned to a draft-guidance tracking plan. 3) Track the Federal Register notice and plan whether to submit comments within the window described by FDA (90 days after Federal Register publication).

Fda update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Health Canada update requires triage for Local Affiliate Compliance, Inspection Readiness, Risk Management; confirm local obligations and document follow-up actions.

Fda update requires triage for Local Affiliate Compliance, ICSR Submission, Device Vigilance; confirm local obligations and document follow-up actions.

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

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

Health Canada update requires triage for Local Affiliate Compliance, Device Vigilance, Inspection Readiness; confirm local obligations and document follow-up actions.

Review and update labeling processes in accordance with the newly published safety-related changes for affected products.

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

Regulatory intelligence teams should review ongoing studies and compliance with postmarketing requirements for the drugs listed, specifically focusing on their deadlines for completion and the nature of the studies required.

Regulatory intelligence teams must update workflows to exclude clove oil as an anesthetic for fish and ensure compliance with the guidance, including awareness of approved alternatives.

Regulatory intelligence workflows should address this enforcement action as part of ongoing compliance monitoring regarding the sale and promotion of unapproved therapeutic goods.

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

Implement a gap analysis for 505(b)(2) applications to identify safety data needs and adjust safety monitoring systems as necessary to accommodate new product characteristics.

MAHs and sponsors must enhance their pharmacovigilance systems to monitor microbiome-specific safety issues, comply with established safety standards, and address concerns related to antimicrobial resistance.

Implement operational changes to assess and process consumer reports on side effects, ensuring additional resources are allocated for evaluations.

Sellers and distributors are mandated to cease the sale and distribution of the affected products immediately and comply with penalties for non-compliance, which may include fines up to RM50,000 or imprisonment.

Sellers must stop the sale and distribution of the canceled products immediately and monitor for compliance with NPRA regulations to avoid legal penalties.

Clinical safety and pharmacovigilance teams must ensure that their SUADR reporting processes are aligned with the new 7-day and 15-day notification timelines, and maintain robust systems for collecting safety data from international sites.

PV teams must prepare and finalize safety-related briefing materials, including risk management plans and protocols, for initial submission by September 2026.

Stakeholders must prepare to submit comments regarding the proposed recommendations for PDUFA reauthorization by the deadline of October 16, 2026.

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.

Stakeholders must prepare for discussions about the integration of QSP methods in investigational new drug (IND) submissions, including a review of IND data packages to align with the new recommendations.

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.

Stakeholders involved in biosimilar product development must review the draft guidance, focus on comparative safety assessments, and submit relevant comments by the deadline of October 2, 2026.

Clinical safety and pharmacovigilance teams must update their study protocols and adverse event reporting procedures to align with the revised guidance by October 2, 2026.

Map this update to local PV compliance processes and update SOP/work instructions, ownership, and due dates for implementation evidence.

MAHs are required to ensure their safety database systems are configured to the updated E2B(R3) specifications and verify B2B gateway connections before the August 2026 deadline.

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.

Update electronic safety reporting systems and pharmacovigilance databases to implement new rules to ensure all submissions use GENC 3-letter country codes and include the required fields as of July 20, 2026.

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

Holders of Certificates of Registration and Clinical Research Organisations must update their safety databases and reporting workflows to comply with the new electronic reporting requirements for AEs and SAEs.

MAHs are encouraged to transition to the new digital service for all pharmacovigilance reporting and utilize the feedback function during the beta phase to improve the service.

Healthcare providers must ensure patient registrations and comply with adverse event reporting as per the renewed compassionate use framework, which includes the collection and analysis of safety data.

Ensure compliance with updated SUSAR reporting timelines (15 days), notify SFDA of Phase IV trials within 20 working days post-IRB approval, and prepare for the financial fee of 15,000 Saudi Riyals for clinical trial evaluations.

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.

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

Return recalled products to place of purchase for refund or contact Customer Care for return arrangements.

1) Map portfolio to MHRA’s Category 1 vs Category 2/NI MA status referenced in the Windsor Framework PV guidance; 2) Update PSUR submission SOPs/work-instructions and submission trackers to ensure Category 1 PSURs route via the MHRA PSUR portal and Category 2/NI MA PSURs route via the EU PSUR Repository (and confirm when no separate MHRA submission is needed); 3) Re-check related MHRA PV procedure guidance for any additional submission/documentation expectations impacting signals, RMPs and PASS.

Ask the safety/device vigilance and PV CSV leads to: (1) confirm whether any marketed/fielded SaMD/AIaMD uses adaptive ML or planned updates that would fit a PCCP-like approach; (2) review current change-control SOPs and technical documentation to ensure change governance and transparency artifacts are captured and retrievable; (3) verify post-market/vigilance processes explicitly account for algorithm updates (e.g., monitoring after updates, escalation criteria).

Developers of NAMs are encouraged to participate in early dialogues with EMA and are now able to submit NAM-derived data for independent evaluation under a voluntary data submission pilot.

Manufacturers must familiarize themselves with the new procedure, including creating an EMA account and understanding the timelines for submitting the required briefing documents according to the established timetable for 2025 and 2026.

AZRL LTD must proceed with the recall of FastPen 40mg from all locations and suspend marketing activities until compliance is verified.

Patients will be treated with an initial dose of 19 mg of Mimrylo, administered weekly, with careful monitoring to maintain hematocrit levels below 45%. The operation of post-marketing surveillance will be affected due to the introduction of this new drug.

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

Implement new labeling requirements for choline salicylate products by November 5, 2026, including specific warnings as outlined.

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.

Review and verify that any cosmetic products sourced or distributed comply with the manufacturers listed in the updated QUEST system.

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

Regulatory teams should integrate the new labeling information into their literature surveillance processes to ensure compliance and accurate communication surrounding Spikevax usage.

Healthcare organizations should review the NPRA annual report to ensure compliance with updated safety monitoring practices and adjust their reporting and signal management processes accordingly.

Regulatory requirements for daratumumab will need to be reviewed in light of the orphan designation status granted by the EMA.

Update all internal and external communications, labels, and marketing materials to reflect the new product name, Svariya, instead of Rivaroxaban Koanaa.

Clinical safety and pharmacovigilance teams should review the FDA guidance and adjust their monitoring plans to ensure they align with the newly provided recommendations regarding safety endpoints and data collection processes.

Marketing Authorisation Holders (MAHs) and applicants must register new sites and organisations in the OMS before any regulatory submission and ensure alignment of their submission documents with the latest guidelines.

Entities affected by this notification must review their plasma product lot processes and ensure compliance with NPRA regulations. Affected stakeholders should adjust workflows to address non-compliance issues.

Implement an immediate review of affected vaccine lots and ensure all relevant stakeholders are informed of the compliance issues for Signal Management processes.

Organizations must increase scrutiny and evaluation of vaccine safety profiles for lots identified in the notification of non-compliance.

MAHs and sponsors of priority medicines must review the updated PRIME guidance to ensure compliance with new interaction expectations, particularly regarding risk management planning and post-authorisation safety monitoring.

MAHs and SMEs must review the updated fee structures and assess the potential for fee reductions on safety-related submissions to align with the new regulatory framework.

Sponsors in the ILAP must update their Target Development Profiles to reflect the revised TDP and coordinate closely with pharmacovigilance teams for alignment with the new roadmap.

Regulatory stakeholders should submit comments regarding the QMIN by the deadline of November 3, 2026, to influence the development and implementation of this initiative.

Review and update product monitoring and risk management plans to align with the new safety assessment standards and AMR surveillance requirements as specified in the updated guidance.

Marketing authorisation holders must update Product Information (SPC and PL) in accordance with CVMP monthly recommendations, and ensure local affiliates are informed of new safety instructions.

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.

All electronic PV submissions must undergo new validation checks in accordance with the updated criteria to ensure compliance and accuracy.

MAHs must execute safety communication plans, update Risk Management Plans (RMPs), and revise product information including the Summary of Product Characteristics (SmPC) and Package Leaflet.

MAHs must ensure draft protocols are placed correctly in the CTD and that submission planning considers the clarified assessment timelines, with RMP updates contingent upon PRAC endorsement.

Clinical safety and pharmacovigilance teams must implement new safety monitoring protocols and ensure adequate assessment of abuse potential as stipulated in the guidance.

Incorporate enhanced requirements for monitoring pregnancy-specific safety signals into existing pharmacovigilance practices.

Pharmacovigilance teams must adopt a structured classification approach to risk analysis, impacting how cases are assessed and notified.

MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.