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

Posted by: , Posted on: - Categories: Medicines in pregnancy
girl holding a pill and a glass of water

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

Posted by: , Posted on: - Categories: Improving Our Services
Image of Martin O’Kane, MHRA, and Catherine Blewett, HRA

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 …

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

Posted by: , Posted on: - Categories: Variations
grey jigsaw with one piece missing

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, …

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

Posted by: , Posted on: - Categories: 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)

Posted by: , Posted on: - Categories: 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 …