Reference medicinal products (RMPs)

AI Summary

This guidance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines critical changes to Reference Medicinal Product (RMP) requirements for generic drug applications starting January 1, 2025. These updates coincide with the full implementation of the Windsor Framework. Under the current regulatory framework, defined by the Human Medicines Regulations 2012, rules for RMPs differ between Great Britain and Northern Ireland. However, from 2025, a unified approach will apply to UK-wide marketing authorizations. All RMPs must have been authorized in the UK for at least eight years. Acceptable products include those authorized directly by the MHRA or those converted from former European Union (EU) authorizations. Importantly, EU marketing authorizations that were not converted to Great Britain licenses will no longer be valid as RMPs for UK-wide applications. Key actions for pharmaceutical companies include transitioning away from 'European Reference Medicinal Products' for new UK-wide submissions after the deadline. While authorizations granted before 2025 remain valid, new applicants must ensure their reference data originates from UK-approved sources. Additionally, if companies use non-UK comparator products in clinical studies, they must provide robust evidence that these products are equivalent to the UK version. This guidance ensures that the UK maintains a consistent regulatory standard for medicine safety and efficacy as it moves away from shared EU processes.