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 …
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 …
Don’t worry, we’re not talking Shakespeare and it’s ‘B’ for baselines – we want to help you understand when a baseline might be required and what it should contain. From January 2019 the EU eSubmissions Roadmap will mandate the use …
March 19th saw the third variations masterclass & workshop (a repeated, single day event) conclude with an overall attendance of 143 delegates from 104 companies. Presentations were held in the morning covering the submission of variation procedures involving Patient Information …
We are delivering cutting-edge technology to improve processes, introduce automation and enhance customer services throughout 2018. Our Information Processing Unit is in the middle of a four-year reform programme designed to improve its services, operations and overall efficiency while …
Administrative changes can be either Type 1A or Type 1B and are considered minor variations. These include company name, postcode and/or address changes, the removal of redundant sites, and drug substance name changes. Additionally, changes can include ‘Quality Review of …