UK Proposes Sweeping Changes to Rules Governing Clinical Trials
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations, including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information.
MHRA said the agency reviewed more than 2,000 stakeholder responses when devising the slate of proposals and noted that the UK’s trial landscape has “shifted,” given that sponsors have many competitive, alternative options of where to launch their trials.
In an October 2022 report, the Association of British Pharmaceutical Industry (ABPI) warned that the UK’s National Health Service patients are facing reduced access to innovative treatments because the number of industry trials initiated in the UK annually dropped by 41 percent from 2017 to 2021.
Now, as part of its efforts to streamline the trials process and shore up its international profile, MHRA said it will seek a combined MHRA/research ethics review and would align with International Council for Harmonization’s (ICH) good clinical practice guideline, ICH E6.
In a new requirement, MHRA also said that sponsors would be required to register trials with the World Health Organization within 12 months of the end of the trial unless a deferral has been agreed by or on behalf of the research ethics committee.
Beyond initiatives to improve transparency and speed, the proposed reforms also aim to reach more diverse populations. The agency has promised to issue guidances on diversity in clinical trials but said it would not be imposing diversity targets or quotas.
MHRA did not set a timeline for when these changes would be implemented but did say it would begin working with lawyers to draft new legislation to reflect the regulatory updates, adding that it aims to ensure flexibility while providing for legally enforceable requirements.
ABPI said it welcomed the agency’s “commitment to work with our industry to co-develop new regulatory guidance and their pragmatic approach to patient and public involvement and trial diversity.”
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