Regulatory intelligence & pharmacovigilance updates, mapped to your role.

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

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.

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.

Sponsors and clinical safety teams must revise and enhance their protocols for impurity analysis and immunogenicity assessments in alignment with the newly released guidances, ensuring all future ANDAs meet updated safety criteria.

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.