BRIEF—UK regulator provides Brexit planning guidance

The UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has provided a new guidance document covering the conduct of clinical trials in the event of the UK leaving the European Union without a negotiated trading agreement.

The guidance adds to a growing body of documents the agency has prepared to help drugmakers prepare for this eventuality.

The latest guide covers required changes to the trial sponsor/legal representative, IMP certification and importation and amendments to REC.