Country Guides

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.

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.

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.

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.

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from the overview (e.g., RMP note to reviewer, Canadian-specific addendum, RMP summary template) and map deltas vs the superseded 2015 approach. 2) Update Canada submission checklists/work instructions for the 1 July 2025 effective date, including the requirement that the RMP include a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.

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.

Health Canada update requires triage for Local Affiliate Compliance, Inspection Readiness, Risk Management; 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.

Manufacturers must demonstrate that any variances from the foreign authorized drugs do not adversely affect safety or effectiveness when filing for deeming under this new framework.

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.

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.

Stakeholders must integrate the new guidance into their signal management and literature surveillance processes to ensure compliance with updated PMDA expectations.

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

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.

MAHs should prepare for enhanced regulatory collaboration, including potential joint oversight activities and reduced market friction between the UK and US due to closer alignment in regulatory decisions.

Stakeholders, including those involved in labeling and signal management, should consider the published comments to align future processes with the regulatory expectations detailed in the draft ICH E22 guideline.

Review updated PMDE Program procedures on CDA-AMC website and assess impact on current post-market surveillance activities in Canada.