UK To Use COVID-19 Learnings To Speed Up Review Of Other Trials
A new pre-assessment service for COVID-19 clinical trials that was established by the UK medicines regulator to cut down on review times is being extended to a limited number of other kinds of trials.
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The UK is revising its clinical trial processes to align them with the new EU Clinical Trials Regulation so that companies can seek authorization just as easily in the UK as in other EU member states, irrespective of the situation after Brexit.
The UK Medicines and Healthcare products Regulatory Agency is developing a series of guidance documents on general points to consider when planning a trial to generate real-world evidence. The first document in this series focuses on prospective randomized trials.
With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.