MHRA has published the consultation response on their proposals for legislative changes for clinical trials.
“We will introduce new legislation and guidance as part of a swathe of new measures that represent the biggest overhaul in UK clinical trials regulation in over 20 years. These bold new measures will make the UK one of the best countries in the world to conduct clinical research for patients and researchers.
The package of reforms will cement the UK as an attractive destination for trials, including global “multi-site” trials, by making application processes more proportionate, streamlined and flexible without compromising on safety.
The new framework will also improve public transparency of clinical trials that are being conducted, through new legal requirements to register clinical trials, to publish a summary of results, and share trial findings with trial participants.
The reforms, which follow a public consultation, are made possible with the help of the public and the research community, including the Health Research Authority and the Department of Health in Northern Ireland.”
MHRA have also issued a press release relating to this.
This overhaul is likely to affect companion diagnostics and combination products which also have requirements under the Human Medicines legislation.
