Clinical trials applications for Coronavirus (COVID-19)

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its procedures for COVID-19 clinical trial activities as of March 2022. Under the current regulatory framework, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) must be submitted via the combined review service through the Integrated Research Application System (IRAS). This streamlined approach provides a single application route and a coordinated review by the MHRA and the Research Ethics Committee. Due to the changing public health landscape and vaccine availability, the MHRA has transitioned from prioritized assessments to processing all COVID-19 applications according to standard timelines. Required actions for sponsors include using the official 'COVID-19' acronym in study titles as per WHO guidance and directing all technical queries to the dedicated Clinical Trials Helpline. While the agency continues to offer regulatory support and scientific advice meetings, it does not manage trial enrollment or participant eligibility; individuals interested in volunteering are directed to consult public registers or their healthcare providers. This guidance signals a return to routine regulatory operations while maintaining support for ongoing pandemic-related research.