MHRA Issues Brexit Guidance on Comparator Products for Generics

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released new guidance on sourcing comparator products for bioequivalence, pharmacokinetic and therapeutic equivalence studies in the event that the UK leaves the EU without a formal deal.

In the case of a no-deal Brexit, comparator products should be sourced from the UK market, the agency advised. But if not, the applicant should offer evidence that the comparator is representative of the reference product for the new generic medicine or other abridged marketing authorization application.

Applicants may be able to compare their proposed medicine with a non-UK sourced comparator product, but the application would still need to point to an eligible UK reference product.