Comparator products in bioequivalence/therapeutic equivalence studies

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on using non-UK comparator products for bioequivalence and therapeutic equivalence studies. This framework applies to Great Britain through December 31, 2024, and expands UK-wide on January 1, 2025, following the Windsor Framework implementation. The guidance operates under the Human Medicines Regulation 2012, facilitating global development by allowing applicants to reference products from countries with equivalent standards, such as the USA, EU, and Japan, provided they represent the UK reference medicinal product (RMP). To ensure compliance, applicants must demonstrate that any differences between the non-UK comparator and the UK RMP are not therapeutically significant. Key actions include providing analytical bridging data, certificates of analysis, and testing results for at least three batches of each product. If the products are confirmed as identical by the manufacturer, requirements for analytical data may be reduced. However, for complex products—such as those with narrow therapeutic windows, non-oral administration, or variable absorption—the MHRA requires early consultation. Failure to adequately prove representativeness will result in the application's rejection or a requirement to conduct new studies specifically against the UK RMP.