Faster, aligned decisions are set to bring medicines to patients sooner.
NICE and the Medicines and Healthcare products Regulatory Agency (MHRA) have launched a new aligned pathway (from 1 April) designed to move NICE’s decision-making forward so it runs alongside MHRA’s review. The aim is for decisions on licensing and value to be made at the same time, helping patients access new medicines 3 to 6 months faster.
Alongside this, the organisations are introducing an improved integrated scientific advice service:
-
Single entry point, one meeting and one payment.
-
Advice will be independent yet aligned on topics where conflict can arise, such as endpoints and patient populations.
-
Designed to clarify regulations and evidence requirements earlier in development to support the new timelines.
NICE and MHRA announced the changes at the NICE conference in Manchester on 17 March. Companies can join the official webinar at 2pm on Wednesday 25 March.
In October 2025, companies were invited to register as early adopters; 27 companies signed up. The first guidance is expected in June 2026.
