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Generic and Biosimilar Medications

MHRA performance

The MHRA regulates medicines covering the whole of the UK, including new licences and variations to existing ones. From 2025, all UK-bound medicines are required to have a 'UK only' label to prevent them from being supplied to the EU market. Licensing marketing authorisation (MA) timelines are 210 days for new generic applications and 180 days for biosimilars. As the sector body for off-patent medicines, we work closely with MHRA colleagues on performance to ensure awareness and understanding of industry requirements.

Collaborative approach

We work very closely with the MHRA to ensure their services fulfil the needs of our sector. We regularly meet with key senior leaders from the agency to discuss ideas and review new areas of collaboration. This close working relationship has been important in removing a backlog in licensing approvals which has built up in recent years.

 

Now that the MHRA is a standalone regulator, we would like to see more policies that will set the UK apart and help companies decide to launch new products here first. For example, we would like the licensing timelines for generics and biosimilars to be halved to 100 days.

 

The current target (the 'statutory timeline') has remained unchanged for decades and mirrors the EU's. We believe that shortening the timeline is an achievable goal which would greatly add to the commercial attractiveness of the UK and allow the NHS to access medicines more quickly.

 

 

 

 

 

 

Generic and Biosimilar Medications

Approval timelines

Companies should plan on 18 months to receive MHRA national approval for applications submitted and validated before September 2024. From 2026, Medicines UK's aim is to agree with MHRA steadily faster approval rates for generic applications. This should encourage more companies to make standalone UK applications.

 

As well as applying to the MHRA for a standalone UK MA, companies can apply to go through the International Recognition Procedure, whereby MAs granted by certain countries are fast-tracked through a 60–110 day timetabled process. This covers MA grants made to regulators in the EU, Switzerland, US, Canada, Singapore, Japan and Australia.

 

 



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