From today, the Medicines and Healthcare products Regulatory Agency (MHRA) is welcoming applications for the Early Access to Medicines Scheme (EAMS) from the pharmaceutical industry and research organisations.
This scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation and where there are no suitable alternative licensed treatments.
There are two parts to the scheme. The first is a promising innovation medicine (PIM) designation which will be given after assessment of clinical data and provides an early indication that the specific product has potential for the EAMS scheme.
The second is where a scientific opinion is issued based on the benefit risk profile of the medicine. Positive scientific opinions will be made available on the MHRA’s website to assist doctors and patients in making treatment decisions, and inform them of the risks and benefits of the product.
Chief Executive of the Medicines and Healthcare Products Regulatory Agency, Dr Ian Hudson said:
“This is a significant step forward for the earlier availability of medicines in the UK and we look forward to receiving applications to the scheme.
“The launch of this scheme will mean that the MHRA issues an opinion that supports prescribers in deciding to use an unlicensed medicine for conditions where there are no or inadequate treatment options available to them.
“This scientific opinion will follow after a review of the data submitted by the applicant to the scheme and will describe the benefits and risks of the medicine.”
“Companies can apply via our dedicated EAMS webpage www.mhra.gov.uk/earlyaccesstomedicinesscheme or eams@mhra.gsi.gov.uk.“