The MHRA is set to introduce a new scheme which aims reduce the time taken by the agency to approve the lowest-risk clinical trials. It has set a target of cutting approvals times by half, is a move it claims will benefit UK patients, the healthcare system and the life sciences sector.
The revised notification scheme will allow for an approval of the lowest-risk clinical trials without the need for a full regulatory assessment. However, a research ethics committee opinion would remain a requirement. Outlined in the MHRA’s clinical trials consultation, the scheme was endorsed by 74% of respondents.
“We are excited to introduce this new streamlined clinical trials system. Clinical trials regulation should be flexible and risk-proportionate so that the regulatory requirements are geared to the risk that a trial presents.
“Our new notification scheme is exactly that. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety. This will help give UK patients quicker access to the potentially life-saving medicines being studied,” said Dame June Raine, Chief Executive of the MHRA.
The scheme means that initial applications for phase 3 and 4 trials deemed to be at lowest-risk, will be processed by the MHRA within 14 days instead of 30 days. To qualify for inclusion the sponsor must demonstrate that the trial meets the MHRA’s criteria and confirm that there are no known safety issues with the investigational drug.
It forms a significant part of the regulator’s wider proposals for legislative changes to clinical trials’ regulation and seek to make the UK one of the best countries in the world to conduct clinical research.