MHRA-NICE Aligned Pathway Accelerates NHS Patient Access to Medicines
Summary
The MHRA and NICE have launched an aligned pathway that synchronises regulatory approval with health technology assessment, enabling simultaneous delivery of both decisions. This coordination is expected to reduce the time for new medicines to reach NHS patients by 3-6 months compared to sequential processing. The initiative includes a webinar on the launch of the MHRA-NICE Aligned Pathway and Integrated Scientific Advice services.
“By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
The MHRA and NICE have established a coordinated pathway that aligns regulatory approval timelines with health technology assessment decisions. Rather than processing regulatory approval followed by separate reimbursement evaluation, both decisions will be delivered simultaneously.\n\nPharmaceutical companies planning UK market entry and NHS patients awaiting new treatments are the primary beneficiaries of this change. Manufacturers submitting products for UK approval may experience shorter overall time-to-market, while healthcare providers gain earlier access to approved therapies. The initiative does not alter substantive regulatory or assessment standards—only the timing and coordination of decisions.
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Apr 9, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Guidance
Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
From: Medicines and Healthcare products Regulatory Agency Published 1 April 2026 Last updated 9 April 2026
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Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway
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This will be achieved as the National Institute for Health and Care Excellence’s (NICE) decisions are brought forward to align with the Medicines and Healthcare products Regulatory Agency (MHRA), resulting in the delivery of regulatory and health technology assessment decisions at the same time.
Published 1 April 2026 Last updated 9 April 2026 show all updates
1.
9 April 2026
Added video of webinar on the launch of the MHRA-NICE Aligned Pathway and Integrated Scientific Advice services
2.
1 April 2026
First published.
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