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

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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

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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)

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  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 …

Delivering new services to put our customers first

Posted by: , Posted on: - Categories: Improving Our Services, Variations

  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 …