The Medicines and Healthcare products Regulatory Agency has introduced a series of changes, including an upcoming overhaul of its clinical trial legislation, to enhance its performance in the future, chief executive Dame June Raine writes.
There can be no doubt that recent years have signified a period of great change for the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), as highlighted in the recent LifeArc conference.
Dame June Raine is the chief executive of the Medicines and
In that time, we have become a standalone regulator following our exit from the EU, a transition that was completed during the COVID-19 pandemic – the most
BioMarin’s ultra-rare disease drug Brineura has breached cost-effectiveness thresholds for highly specialized treatments in England and looks set to be denied routine funding on the National Health Service.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
England’s health technology assessment institute, NICE, must ensure that there is clarity for manufacturers on how its methods and processes might change following testing in its sandbox environment, the Association of the British Pharmaceutical Industry said.
Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.
While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.
The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.
