Welcome to the March issue of the Med Tech Regulatory Reform blog series. As the leader of a team which includes many talented female scientists, I am particularly delighted to be publishing this at the start of British Science …
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 …
...complex innovative trial designs, such as basket and umbrella trials, which are being used with increasing frequency. We are committed to engaging with Clinical Trial Sponsors on novel trial designs,...
...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 …