Industry pushes back on MHRA no-deal Brexit plans

With the U.K. and EU likely to determine whether or not a Brexit deal can be reached in the coming weeks, U.K. industry groups have criticized MHRA's plan for regulating medicines in the U.K. under a no-deal Brexit as creating an onerous compliance burden for already approved drugs and failing to maintain premarket incentives for Orphan therapies.

The BioIndustry Association and Association of the British Pharmaceutical Industry said a proposed requirement that sponsors provide a copy of the full electronically formatted data set underlying each drug’s current EU authorization by March 2020 would create a hurdle difficult for most companies to meet within the one year grace period. The groups proposed that MHRA should obtain the data directly from EMA, or allow sponsors to submit the full electronic dossier for the drug upon their next submission of a variation application for the same drug...