The new MHRA pipeline planning process

Back in August the MHRA launched their new pipeline process to allow them to better prepare for incoming work. Fusion Pharma attended the latest webinar in September to find out all about this new process.

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What is the MHRA pipeline process?

By requesting that current and potential MA holders provide information on planned and potential future submissions, the MHRA can more accurately predict their workload and allocate staff appropriately.

This new process applies to all companies regardless of size, and will gather a range of information, including proposed submission dates for new MAs and complex variations, along with information on whether scientific advice or pre-submission meetings are required.

The MHRA hopes that this process will lead to ‘smooth, efficient and predictable regulatory process to support patient access’.

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So how is the process completed?

A spreadsheet is available to download from the MHRA website. This should be filled in and emailed to the MHRA on a 6-monthly basis.

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What if my dates change or my project gets pushed out?

The MHRA understand that things do change, and so the dates provided are not binding in any way. However, they do ask if you can keep them up to date when these dates change.

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What happens to my data?

The MHRA understand that a lot of data could be commercially sensitive, and the data is not made public in any way. The data is available to only a limited number of teams within the MHRA for planning purposes only.

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How is this different from UK Pharmascan?

Many companies already input their pipeline information into ‘UK Pharmascan’, so why the duplication? While the MHRA are also downloading and using this data, they have found many discrepancies between the data inputs. They are therefore requesting their own data until they can be sure the two align.

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Is the process mandatory?

While this procedure is not yet mandatory, using it can only help to serve both industry and the MHRA. It could lead to shorter approval times, by having the correct people allocated ahead to the task.

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Further information on the process can be found here.

Written by Sophie Milden