Yesterday (27 June 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials for Medicines: Apply for Authorisation in the UK" that provides detailed instructions on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The recent update was the inclusion of a new section about In Vitro Diagnostic Medical Devices (IVDs). This guide provides information and instructions on the process of applying for authorization to conduct clinical trials for medicines in the United Kingdom.
It outlines the regulatory framework and the necessary steps and requirements for obtaining authorization.
The guidance covers various aspects, including the importance of a well-designed protocol, Registration of clinical trials, Combined review of clinical trials of investigational medicinal products, In Vitro Diagnostic Medical Devices (IVDs), Documents to send with your application, Assessment of the submission, and the overall application process.
The IRAS portal includes a list of documentation to submit for a combined review of your application. The initial combined review assessment will be completed within 30 days of being submitted. Also, there are different fees based on the type of clinical trial application.
To know the complete step-by-step approach on How to apply for a clinical trial authorisation in the UK, click this LINK.
Commenti