The UK government has announced much-awaited reforms to its clinical trials framework, explaining how several existing provisions will be soon replaced with new legislation or guidance. The changes, the government says, will make it faster and easier to gain approval and to run clinical trials in the country.
Under the new framework, the clinical trials application processes will be more proportionate, streamlined and flexible, without compromising on safety. The review processes will be subject to internationally competitive approval timelines and will include more flexibility for sponsors to respond to questions raised by regulators