How the New EU Human Medicines Regulations Will Impact the Industry

Synopsis

On 25 November 2020 the European Commission (EC) published a pharmaceutical strategy document, which they said was the first step in a “complete overhaul” of the medicines legislative framework for human medicines to be proposed in about two years’ time. Commission vice-president Margaritis Schinas told a press conference on 25 November 2020 “We will be completely overhauling the entire legislative medicines framework – a set of rules that is 20 years old and badly needs modernisation”.

The presentation will look at the most important changes in the EU HMRs including those that directly impact UK manufacturers and I plan to discuss the impact of the Windsor Framework.