What we do

NICE has a key role in the evaluation of and access to new and innovative medicines and treatments for the health system, playing an important role in ensuring the UK remains a destination of choice for the life sciences sector.

We work closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to make sure we can publish our guidance in a timely way.

We aim to publish final guidance for all new technologies within 90 days of receiving marketing authorisation.

You can find out more about medicines licensing and applications on the MHRA website.

How it works

  • The MHRA is the UK’s medicines and medical devices regulator.
  • The MHRA can use the International Recognition Procedure (IRP) for products approved from one of the specified reference regulators or the national route for products not suitable for IRP.
  • Visit the MHRAs website for more detailed information on the IRP.

What this means

The applicant makes an application to the MHRA for a GB marketing authorisation through either the IRP or national licensing route.

  • Arrangements and timing of company submissions to NICE are decided based on expected MA date, unless a delay to submission is requested and agreed.
  • Prior to issuing final guidance, NICE will ensure that the MHRA has issued a GB marketing authorisation.
  • In circumstances where there is a delay to the GB marketing authorisation, NICE will delay publication of final guidance.

What the pharmaceutical industry needs to do

To help NICE get the best care to patients fast we ask the pharmaceutical industry to:

  • engage early
  • keep information on UK Pharmascan up to date
  • provide updates on regulatory plans to NICE and the MHRA
  • allow NICE and the MHRA to share operational and planning data.