Final

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.

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.

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.

Sponsors and investigators must develop an implementation plan for the ISO 14155:2026 standard and maintain records for review during TGA inspections, ensuring alignment with updated safety monitoring obligations.

Manufacturers and applicants must utilize the finalized scoring system for new study submissions and ensure post-market safety reports include monitoring for adhesion-related issues as indicators of product quality.

Marketing authorization holders (MAHs) must align their RMP submissions with the updated MFDS checklists to comply with the new review procedures.

PV and device vigilance teams need to review their AVT product portfolios to verify correct classification and ensure adherence to medical device vigilance reporting workflows, especially for those tools classified as medical devices.

Investigators need to modify trial protocols and safety reporting mechanisms in line with the latest ISO 14155 updates to ensure compliance for upcoming high-risk clinical trials.

Manufacturers must generate and maintain scientific, engineering, and clinical evidence demonstrating that their devices meet the Essential Principles for Safety and Performance.

MAHs must update labelling components to meet new criteria, including a minimum font size of 7 points and essential information requirements regarding the medicine's name, strength, route of administration, posology, warnings, and indications as per the guidance. New packaging must be incorporated into stocked products within six months of approval.

MAHs must categorize their proposed label and PIL updates, utilizing the self-certification route for those not requiring full assessment; submissions validated through this route will receive acceptance letters within 14 days.

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.

Developers of MBMPs must align their safety assessment protocols with the MHRA's expectations and are encouraged to engage with the MHRA early to establish appropriate regulatory strategies.

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.

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.

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.

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.

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

Sponsors must adhere to defined meeting types (Type X, Y, Z) and submit meeting packages at least 3 months before planned submissions for OTC monograph drugs, ensuring FDA engagement occurs within set timelines.

MAHs and trial sponsors must align their safety monitoring and data collection workflows with the new GCP principles established in ICH E6(R3) Annex 2.

Healthcare professionals must report all serious incidents involving injectable devices to Swissmedic as outlined in the new guidance.

Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.