MHRA opens Early Access scheme

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.