MedRegs

MHRA and the Bill and Melinda Gates Foundation to look at more effective use of medicines during pregnancy

Paola Coppola, 16 June 2020 - Medicines in pregnancy

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 …

One Hundred Clinical Trial Applications Authorised under the Combined Ways of Working (CWoW) pilot

Martin O'Kane, 4 March 2020 - Improving Our Services

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 …

Survey on novel trials and MHRA advice services – tell us what you think

Kirsty Wydenbach, 23 December 2019 - Improving Our Services

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 …

What is understood by 'deletion of a non-significant parameter'?

Paul Cottingham, 27 June 2019 - Variations

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, …

Combined Ways of Working: innovating the way clinical trials are assessed

Lisa Campbell, 20 May 2019 - Improving Our Services

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 …

Spread the word – clinical trial regulators do not bite!

Kirsty Wydenbach, 15 March 2019 - Improving Our Services

The rumours are still out there about not talking to regulators: they will “just say no”. It’s such a shame we are still hearing this, particularly about the use of complex innovative trial designs, such as basket and umbrella trials, …

Faster approvals for clinical trial applications - what our robots have taught us so far

Ant Foy, 22 October 2018 - Improving Our Services

Here at the MHRA's Information Processing Unit we are getting to know our newest colleagues –five robots called Alpha, Bravo, Charlie, Delta and Echo. While our robots do not need tea breaks or have a social life outside of work, …

Submitting a variation that impacts the SmPC, label and Patient Information Leaflet (PIL)

Paul Cottingham, 7 June 2018 - Variations

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 …

To “B” or not to “B”

petercolwell, 21 May 2018 - eCTD

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 …

Variations masterclass & workshop

Paul Cottingham, 26 April 2018 - Conferences and events, Improving Our Services

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 …

Blog MedRegs

MHRA course on Pharmacokinetics of medicines in pregnancy - understanding how pregnancy affects plasma drug levels