The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit.
Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week. The overarching goals of the plan are to put the UK at the forefront of the life sciences industry, thereby cutting the time it takes for patients to access medicines and to give it a leading role in efforts to cure rare diseases.
To achieve those goals, the government plans to “remove unnecessary bureaucracy for the lowest risk clinical trials, encouraging the rapid introduction of new medicines.” The outgoing EU clinical trial rules were criticized in some quarters for imposing excessive burdens on small, low-risk studies. The planned loosening of the UK rules is part of a push to make it easier for hospitals to trial and make medicines and diagnostics devices.
The government also wants to use the legislation to drive the Medicines and Healthcare products Regulatory Agency (MHRA) to develop regulations to help companies “break new ground in complex clinical trials.”…