MHRA Offers Guidance on Comparator products in BE/TE studies after Brexit
MHRA provides No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies. This guidance provides further information on comparator products used in studies supporting abridged marketing authorisation applications in a no-deal Brexit.
FDA explains that the guidance is meant to help companies understand how not to submit extraneous information or misplaced or missing information that could result in delays, Refusal to File or Refuse to Receive actions.
For the comparison between the RMP and the non-UK comparator products (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.
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