Regulatory Blog

The Early Access to Medicines Scheme (EAMS)  is a regulatory initiative in the United Kingdom designed to provide patients with life-threatening or seriously debilitating conditions earlier access to promising medicines before full marketing authorisation is granted. The scheme is administered by the Medicines and Healthcare products Regulatory Agency (MHRA) and aims to accelerate patient access to innovative treatments where there is a clear unmet medical need. The main obj

The UK regulatory environment now offers two important pathways for bringing innovative medicinal therapies to patients: The Early Access to Medicines Scheme (EAMS) , which permits earlier availability of new medicines under conditions of unmet medical need; and The MHRA’s guidance “ Clinical trials for medicines: apply for authorisation in the UK ” , which provides the regulatory framework for initiating clinical trials of investigational medicinal products. These 2 guidance

The Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance on "Apply for the early access to medicines scheme...