Send and receive information on adverse drug reactions (ADRs)

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a significant update to its pharmacovigilance reporting systems, effective May 28, 2024. This guidance outlines the transition to a new adverse incident database that adheres to the ICH ICSR R3 international standard. While the MHRA will continue to accept safety reports in both R2 and R3 formats, it will exclusively issue all outgoing communications—including acknowledgments and safety reports—in the R3 format. Marketing Authorisation Holders (MAHs) are required to ensure their technical systems can manage these R3 files, as the agency will no longer support R2 exports. Under the regulatory framework of Good Pharmacovigilance Practices (GVP) Module IX, MAHs remain responsible for proactive literature monitoring and the notification of safety signals using prescribed forms. The guidance also clarifies that reports concerning Northern Ireland must utilize the specific 'XI' country code. To maintain compliance, companies must register for the MHRA’s submission portal or gateway. Although no formal transition period is provided between the old and new databases, the MHRA has made a test environment available for companies to verify their system compatibility. These changes aim to modernize safety reporting while ensuring robust monitoring of medicine-related adverse events across the UK.