MHRA Seeks Industry Input on No-Deal Brexit Provisions

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking industry feedback on a potential no-deal Brexit scenario in which the agency would function as a medical device and medicine regulator on its own.

The agency said it would assume its own regulatory responsibilities if post-Brexit negotiations with the EU go sour, including handling new licensing routes, possible new global partnerships, a competitive fee structure and pharmacovigilance duties.

The MHRA called for input from industry, healthcare professionals and the public on the proposed changes in its technical notice, titled “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal.”