Regulatory intelligence & pharmacovigilance updates, mapped to your role.

Manufacturers must implement processes for device registration in swissdamed before placing devices on the market, with immediate attention needed for vigilance-reportable incidents.

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

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.

MAHs must ensure new medicinal product information texts use updated templates by 1 July 2026 and revise existing texts at the earliest opportunity if they include instructions for use.

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.

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.