The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Business Plan for 2025/26, reaffirming its commitment to keeping patients safe and enabling access to high quality and effective medical products through innovation across the UK.
The plan appears forward-looking, acknowledging their purpose as an engine of economic growth and the need to be bold and ambitious in the development of their new strategy beyond 2026.
Of note to our industry is the planned modernisation of the regulatory framework for medicines and medical devices, including diagnostics and AI. The MHRA recognises the need to meet the expectations of the public and industry and regulate in a way which makes the UK a more attractive place to invest in life sciences. Priority areas are set to be identified and policy work will begin before the end of the year.
They will also deliver the actions of the Medical Devices Regulatory reform roadmap, including:
- Publish the results of their consultations on In Vitro Diagnostics, International Reliance, Coronavirus test device approvals and Common Specs by mid Q1.
- Publish a statement of policy intent for early access and innovation by end Q1.
- Publish their In Vitro Diagnostics Roadmap by end Q2.
- Amend pre-market rules to improve safety and access for medical devices by end Q4.
- Deliver the second phase of the AI Airlock project by end Q4.
Other relevant objectives include the development of a streamlined innovation pathway, drawing upon the learnings of the IDAP and ILAP pilots; a new framework to improve the the regulation of therapies for rare diseases and personalised immunotherapies; and the growth and development of the CERSI programme.
The full MHRA Business Plan 2025/26 can be found here.
