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Regulatory Focus™ > News Articles > 2019 > 10 > MHRA Offers No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies

MHRA Offers No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies

Posted 22 October 2019 | By Zachary Brennan 

MHRA Offers No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies

As another delay may push back Brexit to the end of January, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday published new guidance on comparator products (CPs) used in bioequivalence (BE), pharmacokinetic (PK) and therapeutic equivalence (TE) studies to support generic drug and other abridged marketing authorization applications following a no-deal Brexit.

The guidance explains how it may be possible for an applicant to compare a proposed medicinal product with a non-UK-sourced CP, although the application would still be required to refer to an eligible UK reference medicinal product (RMP).

For the comparison between the RMP and the non-UK CP, data on at least three batches of each product would usually be expected, the guidance says.

“If representativeness between the non-UK CP and the RMP cannot be demonstrated, BE and TE studies should be performed against the RMP in the UK,” MHRA notes.

Differences between the non-UK CP and RMP can include: color of tablet coatings (assuming no difference in functionality of coat) or capsule shells, scorelines, embossings and imprintings on solid dosage forms, flavors in liquid dosage forms and container closures.

“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 with the us,” the regulator adds.

MHRA also says the non-UK CP should be authorized in and sourced from a country with similar scientific and regulatory standards as the UK, such as EU/EEA countries, Switzerland, US, Canada, Australia or Japan.

In order to determine the acceptability of the evidence, the licensing authority “must be satisfied that a non-UK CP is representative of the RMP in the UK and that any differences between these two products would not be therapeutically significant,” the guidance says.

Comparator products in Bioequivalence/Therapeutic Equivalence studies after Brexit

MHRA guidance and publications about a possible no-deal Brexit


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Tags: BE, Brexit, generic, MHRA

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