Yesterday (06 November 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Common Issues Identified during Clinical Trial Applications" that identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
MHRA receives between 950 and 1,000 clinical trial authorisation (CTA) applications per year for investigational medicinal products (IMPs), of which the majority (up to 95%) are approved.
The majority of requests for further information or 'grounds for non-acceptance' (GNAs) can be avoided by following the applicable guidance or by providing a satisfactory explanation for not following the guidance.
The recent update includes a new link to updated guidance on recommendations related to contraception and pregnancy testing in clinical trials.
Every trial will have its own peculiarities and each is assessed on a case-by-case basis, which may lead to questions needing to be asked on specific areas. In cases where sponsors do not comply with some of the issues in this guidance, a GNA may not necessarily be granted if they have provided an acceptable scientific (safety) justification.
The standard timeframe for initial assessment of a CTA application is 30 days with an MHRA internal target of an average of 14 days for assessment of phase 1 applications.
Below is a list of the common issues
To know more exclusively about the common issues identified during clinical trial applications, click this LINK