The Windsor Framework

The Windsor Framework

We can’t issue a Regulatory newsletter without referencing The Windsor Framework, can we! On 28th February 2023, the EU and the UK agreed a deal in theory on this new pathway.   What does this mean? The UK Government will no longer proceed with the Northern...

Who the heck are Fusion Pharma anyway?

Who the heck are Fusion Pharma anyway? We are a wonderful bunch of Regulatory Affairs experts!! The more professional answer, however, would be… we are Regulatory Affairs experts who specialise in the UK and EU pharmaceutical arena. We offer a bespoke consultancy...
Early Access to Medicines Scheme

Early Access to Medicines Scheme

The early access to medicines scheme (EAMS) was introduced by the MHRA with the objective of providing patients with life-threatening or seriously debilitating conditions, access to medicines that have not yet received a Marketing Authorisation and addresses an unmet...