CRO

U.K. looks to shake up trial, medicines regulation amid Brexit

As the U.K. prepares to leave the EU, newly elected Prime Minister Boris Johnson has sketched out plans that aim to speed up trials.

Details are still thin, but the so-called Medicines and Medical Devices Bill will be brought forward by the Conservative government, which won a large majority in the general election just before Christmas.

There is a series of ideas in the bill that includes relaxing certain rules around studies and speeding up the approval of new medicines. This will create a “streamlined, internationally competitive” process for approving new drugs and devices, the government said, and would focus on “removing unnecessary bureaucracy” for what it deems low-risk clinical trials.

The bill also aims to boost the range of professions able to prescribe medicines and to enable the Medicines and Healthcare products Regulatory Agency to develop approaches to respond quickly to developments such as the use of artificial intelligence in life sciences.

Last year, there were just under 1,000 clinical trials in the U.K., with more than 1 million patients taking part in research.

The aims of the bill, which will need to become law in order to be affected in the country, are to maintain a competitive edge on the global stage and to make the U.K.’s biopharma and contract research environment attractive for the future.