Intended for healthcare professionals


UK to give “near automatic sign off” for treatments approved by “trusted” regulators

BMJ 2023; 380 doi: (Published 16 March 2023) Cite this as: BMJ 2023;380:p633
  1. Matthew Limb
  1. London

The UK government has announced £10m funding for the country’s medicines and devices regulator to help fast track patient access to innovative drugs and technologies.

Under a new approach, the Medicines and Healthcare Products Regulatory Agency (MHRA) would give “near automatic sign off” for treatments already approved by “trusted” regulators in other parts of the world such as Europe, Japan, or the US.

Announcing the move in his spring budget1 on 15 March, the chancellor Jeremy Hunt said that from 2024 MHRA would put in place the “quickest, simplest regulatory approval in the world for companies seeking rapid market access.”

The UK regulator intends to explore “recognition route” partnerships with bodies including the US Food and Drug Administration (FDA).

The MHRA would still be responsible for approval of all “recognition route applications” …

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