Periodic Safety Update Reports (PSURs) for medicinal products

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the mandatory requirements for Marketing Authorisation Holders (MAHs) regarding Periodic Safety Update Reports (PSURs). Operating under the Human Medicines Regulations 2012 and Good Pharmacovigilance Practices (GVP), the regulatory framework ensures that the risk-benefit balance of all approved medicinal products in the UK is consistently monitored throughout their lifecycle. Although this is a general guidance document rather than a specific company inspection report, it sets the compliance standards that all MAHs must follow. Key actions required include the submission of comprehensive reports that analyze a product's safety, efficacy, and effectiveness. Companies must adhere to specific submission cycles—initially every six months after receiving a UK Marketing Authorisation—and follow the European Reference Date (EURD) list for specific substances. Reports must be submitted via the MHRA Submissions portal within 70 to 90 days of the established 'data lock point.' A critical compliance requirement is that MAHs must not delay notifying the MHRA of significant new safety information; emerging safety signals must be reported immediately via email rather than waiting for the periodic PSUR submission. While generic and certain herbal medicines are often exempt, all other MAHs must provide integrated benefit-risk analyses and summaries of risk-mitigation activities to maintain regulatory standing. Failure to provide UK-specific annexes when requested or neglecting to include global clinical trial data constitutes a breach of these reporting guidelines.