UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Monday and Tuesday released 16 new and updated guidance documents, mostly related to marketing authorizations, variations and licensing.

A couple of the guidance documents deal with how MHRA will authorize new medicines in the event of a no-deal Brexit, including guidance on how the agency will handle centralized applications that are still pending on exit day, approaches for products approved or pending in the decentralized procedure (DCP) or mutual recognition procedures (MRP), converting centrally authorized products to UK marketing authorizations and certain new routes of assessment for MHRA’s evaluation of marketing authorization applications (MAAs). Such new assessment routes would include targeted assessments, accelerated assessments and rolling reviews.

The targeted assessment means MHRA will evaluate MAAs alongside the European Medicines Agency’s Committee for Medicinal products for Human Use (CHMP) assessment reports submitted by the applicants. The guidance says MHRA will reach its opinion on approvability within 67 days of submission of a valid application to the MHRA.