GovWire

Overview

The 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 when there is a clear unmet medical need.

Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made.

The opinion lasts for a year and can be renewed.

The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.

The scientific opinion will be provided after a 2-step evaluation process:

1. the promising innovative medicine (PIM) designation
2. the early access to medicines scientific opinion

See the number of applications made to the early access to medicines scheme for the promising innovative medicine (PIM) designation and the scientific opinion for more information.

Promising innovative medicine (PIM) designation

The PIM designation will give an indication that a product may be eligible for the EAMS based on early clinical data. The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed.

See guidance on applying for a PIM designation (PDF, 187 KB, 3 pages).

Scientific opinion

The scientific opinion describes the risks and benefits of the medicine based on data gathered from the patients who will benefit from the medicine.The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.

View guidance on applying for a scientific opinion (PDF, 178 KB, 6 pages), including the pre-submission meeting.

Pre-submission meeting

If you want to apply for an EAMS scientific opinion from MHRA you must have a PIM designation. You should also attend a pre-submission meeting with MHRA to:

• ensure that your product is suitable for an EAMS scientific opinion application
• discuss the format of the data you need to submit to support the opinion

To apply for a pre-submission meeting fill out the pre-submission meeting request form (MS Word Document, 322 KB) and send it to eams@mhra.gov.uk.

Apply for a scientific opinion

EAMS public assessment report (PAR)

Following a positive EAMS scientific opinion, MHRA will publish a public assessment report (PAR) and the EAMS treatment protocol on GOV.UK. The PAR will include:

• how the product is used and how it works
• summary of the key clinical studies
• the risks and benefits of the product
• the reason for the positive EAMS scientific opinion
• any uncertainties
• information about ongoing clinical studies
• measures in place to monitor and manage risk

Dates for submission, Day 1 and Day 45

You need to make your EAMS scientific opinion submission by one of the dates below: