UK Body Urges Action On Licensing Delays As MHRA Unveils Guidance For Established Products

Regulator Aims To Shorten Timeframes For Assessment Of Established Medicines

UK MHRA guidance outlining process changes aimed at shortening timeframes for assessing established medicines has been welcomed by the BGMA, which has emphasized the need to clear the regulator’s current approvals backlog that the association says is exacerbating shortages.

Clock moving fast with blur, high speed concept
Speedier approvals are needed to clear the MHRA backlog • Source: Shutterstock

Guidance has been unveiled by the UK Medicines and Healthcare products Regulatory Agency outlining process changes for assessing established medicines that are aimed at shortening timeframes for assessment.

But while the British Generic Manufacturers Association has welcomed a faster assessment process, it has also underlined the need to clear the MHRA’s current backlog of approvals, urging more definite action on a

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