The MHRA’s early access to medicines scheme (EAMS) aims to give patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation.

EAMS provides an opportunity for important drugs to be used in UK clinical practice in parallel with the later stages of the regulatory process.

It is anticipated that medicines with a positive EAMS scientific opinion could be made available to patients 12 to 18 months before formal marketing authorisation.

In collaboration with NHS England, we offer an EAMS engagement meeting to assist companies as they navigate through the process.

EAMS meetings

Preparing for the EAMS period can be challenging. The joint NICE and NHS England meeting can help to ensure you are ready for NHS patient access and subsequent NICE appraisal.

An EAMS meeting can:

  • Provide expert feedback on your data collection plans for the EAMS period from the perspectives of  NICE and NHS England.

  • Help you to understand whether NHS England can accommodate your plans within the timescale available.

  • Provide insights into flexible pricing options and managed access approaches that you may want to consider for your technology.

Our meetings carry a fee-for-service, not-for-profit charge.

When should an EAMS meeting take place?

Engaging with us and NHS England at the right stage can prevent time elapsing between a positive EAMS scientific opinion and patients accessing the EAMS medicine.

To get the most value from our EAMS meetings please get in touch as soon as you have requested an MHRA pre-submission meeting.

We aim to hold the meeting before the MHRA issues the day 45 preliminary EAMS scientific opinion.

See the MHRA's list of key dates for EAMS scientific opinion

EAMS and NICE

To understand the involvement of our Office for Market Access and Technology Appraisal Programme in the EAMS process see our:

We also participate in the strategic group supporting the EAMS scheme:

EAMS government-industry task group and supporting material to help explain the scheme

How we can help

We are preparing to submit for an EAMS scientific opinion. We’re not sure whether the data we want to collect will be useful for HTA purposes or whether our plan could be accommodated within the NHS.

We’re also unsure about the suitability of different flexible pricing or managed access approaches for this particular technology…’