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NHS patients on fast track to get breakthrough drugs approved by foreign regulators

Patients will have access to cutting-edge drugs sooner under plans to fast-track the approval of medicines already reviewed by foreign regulators.

Staff at the UK’s Medicines and Healthcare products Regulatory Agency announced “international recognition routes” to streamline tests.

Drugs approved in Australia, Canada, the EU, Switzerland, Japan, Singapore and the US will qualify.

The scheme will let the UK capitalise on the expertise of trusted overseas partners while still making the final decision about whether a product should be available here.

MHRA chief executive Dr June Raine said: “By fast-tracking access to approved products from other countries, we’re ensuring that innovative healthcare solutions reach those in need without delay.”

Work is under way on a similar system for medical devices.

The regulator can still reject drugs approved by another country if it decides there is insufficient evidence that they are safe and effective. However it is hoped the framework will cut costs and accelerate checks.

Backed by £10million from the Treasury, the plan follows the success of initiatives such as Project Orbis – a partnership involving the US and Australia which has sped up the approval of 16 cancer drugs since 2021.

Dr Raine said the MHRA’s Innovative Licensing and Access Pathway was “helping reduce the time to market for innovative treatments by developing medicines that are both regulatory and access ready”.

She added: “We will contribute to the UK’s ambition to be a global science superpower, by making the UK one of the best places in the world to bring life-changing healthcare products to patients safely.”

Claire Machin, the executive director of the Association of the British Pharmaceutical Industry, said details of the countries included “marks an important step forward for this promising initiative which we hope will contribute to faster access to new medicines”.

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