A brave new world for the regulation of medicines, devices and IVDs in the UK


For some months, multiple statements from different parts of the Government have suggested that the UK will adopt a new approach for medicines and medical devices (including diagnostics) to be commercialised in the UK.

The consensus here at Bristows was that the UK would allow most products approved in trusted jurisdictions (such as the EU and the USA) to access the UK market with a very light touch additional review, and possibly automatic access for devices.

This would liberate the MHRA to work closely with developers of innovative therapies and products that would benefit from early collaborative involvement with regulators. In the context of medicines, the MHRA has already taken steps to support innovation with the Innovative Licensing and Access Pathway (ILAP) and a similar pathway has been proposed for Innovative MedTech.

These initiatives built on the efforts and experience during the pandemic when the MHRA was able to work nimbly with industry to get products to market quickly without compromising safety.

Sir Patrick Vallance, the UK Government Chief Scientific Adviser, wrote to the Chancellor on 8 March 2023 requesting suggesting changes that the MHRA could implement to help free up resources to focus on the most innovative products. Sir Patrick specifically suggested that the MHRA adopt a broader approach to the mutual recognition of products already approved by trusted international partner organisations, particularly for well-established technologies.

In the Chancellor’s Spring Budget Speech, the Government appears to have accepted these requests stating that the MHRA will have the quickest, simplest, regulatory approval in the world. While the speech was short on detail, the Chancellor stated that from 2024, the MHRA will adopt:

  • a different model which will allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as the US, Europe or Japan.
  • a swift new approval process for the most cutting-edge medicines and devices to ensure the UK becomes a global centre for their development.

The Chancellor also announced that the MHRA will receive an extra £10m over the next two years. This will help the MHRA reduce its operating deficit of £11.4m in 2021/22. The main reason for this deficit was the investment made in transforming the agency following the UK exit from the EU.

It is clear that the Government intends to adopt a very light touch to the approval of medicines and medical devices that have been approved in the EU, US or Japan.

The next few months promise to be very interesting for the Life Sciences sector in the UK.

Life Sciences Summit 2023:

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