UK medicines agency releases no-deal Brexit guidance

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on how to source comparator products for generic drug applications in the event of a no-deal Brexit.

Guidance V13F21

Following the UK referendum result to leave the European Union in June 2016, there has been much confusion regarding how the UK will regulates its medicines outside of the European Medicines Agency (EMA) framework. EMA released guidance on this issue in 2018 [1] and now the UK Government has released additional guidance on what will happen in the event of a no-deal Brexit.

The MHRA guidance explains how abridged marketing authorization applications will be processed in the event of a no-deal Brexit, and in particular how applicants will source comparator products. Comparator products are used in bioequivalence, pharmacokinetic and therapeutic equivalence studies to support generic drug applications.

The Agency states that, in the case of a no-deal Brexit, comparator products should be sourced from the UK market. Although applicants might be able to compare their medicine with a comparator from outside the UK, the application would still need to identify an eligible UK Reference Medicinal Product (RMP).

A comparator from outside the UK should be sourced from a country with similar scientific and regulatory standards, such as the US or EU, Switzerland, Canada or Australia, and comparisons would need data on at least three batches of each product, say the standards. If products show high variability between batches, or are complex biological drugs, more batches may be required.

The guidance states that the licensing authority ‘must be satisfied that a non-UK comparator product is representative of the RMP in the UK and that any differences between these two products would not be therapeutically significant’.

Differences could include changes to the colour of the medication, imprintings on solid dosage forms or flavours of liquid dosage forms. The guidance also states that ‘The overall acceptability of such an approach and the type of bridging data needed will be a case-by-case/product-type decision and is recommended to be discussed upfront’.

If representativeness between the non-UK comparator and RMP cannot be demonstrated, bioequivalence and therapeutic equivalence studies must be performed against the RMP in the UK.

1. GaBI Online - Generics and Biosimilars Initiative. EMA regulatory guidance update to prepare for Brexit []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 10]. Available from:

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Source: UK Medicines and Healthcare products Regulatory Agency

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