The AI Airlock is a pilot programme designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively. Since we announced the pilot cohort in early December, the AI Airlock …
This is the third blog in this series on novel trials, following an initial update on clinical trials and a second on a survey that was launched in December 2019. The survey is now closed, and thank you to everyone …
Physiological changes in a woman’s body during pregnancy can change how quickly a medicine is distributed and eliminated from her body. This can affect plasma drug levels and how well a medicine works. Understanding how and when these changes occur …
We are working with the Bill and Melinda Gates Foundation on an exciting pharmacokinetics (PK) project which should lead to better informed use of medicine during pregnancy and the development of medicines which are safer for use in pregnancy. Our …
Last year we updated you on a pilot program to streamline the way clinical trials applications were reviewed in the UK. Working closely with colleagues in the Health Research Authority (HRA) and across the Devolved Administrations we jointly developed a …
Innovation and supporting the research environment in the UK is a key priority for MHRA. But we know we can do more and be even better. You may have read a previous blog on this very topic (Spread the word …
The Variation Classification guidelines list approximately 350 different types of variation change codes and classification sub-categories. These variations fall under three possible procedure types: TIA, TIB or TII and cover the active substance and finished product, devices and safety, efficacy, …
For a number of years now we have been working with the HRA (Health Research Authority), and in partnership with the Devolved Administartions of the UK, behind the scenes to explore opportunities to improve the services we provide to Clinical …
...discussions, even before the non-clinical data is available if that is what will help your development plan. So do not wait, come and talk to us about your plans. We...
...Clinical Trial Submission Type Zip File Name Regulatory Activity (G Code) Initial Clinical Trial H001 - Not Applicable Amendment Clinical Trial H001 - Not Applicable End of Trial Clinical Trial...
Several variations have a direct or consequential impact on the product information of a Marketing Authorisation (MA), by introducing changes to the SmPC and fragments, labelling and Patient Information Leaflets (PILs); these variations have a range of submission requirements …