Last week the Medicines and Healthcare products Regulatory Agency (MHRA) held a webinar for the launch of the new MHRA RegulatoryConnect Portal that is due to be released at the end of March.
So what is the aim of the new MHRA RegulatoryConnect Portal?
The aim of the RegulatoryConnect Portal is to allow for greater transparency and visibility for regulatory assessments and timelines; this will be welcomed by industry where currently the status of an application is largely unknown. With this portal, Regulatory Professionals will be able to log in and check the status of ongoing applications for their specific company. Eventually the portal should be a one stop shop where you can manage and access all regulatory aspects that are currently available over several MHRA systems.
When is ‘go live’ and how do I gain access?
‘Go live’ is at the end of March! If you are currently registered with MHRA submissions then you will be able to use the same sign in details to log into the new MHRA RegulatoryConnect Portal. An email will be sent to all current users with a link to the new system.
What will happen to current MHRA systems?
This will be release number 1 and release number 2 will follow in November 2024 which will have additional functionality, after this there will be further updates of which the details are yet to be finalised. With release number 1, current systems such as MHRA submissions will continue as is and there will be no decommissioning until further releases are made in November.
What can I access in the RegulatoryConnect Portal on day one?
All pending submissions will be migrated across and you will be able to log in and view the current status. You will be able to see:
- Current Granted View – allows you to see your data and check status of currently approved licences
- Applications – you can find and check the status of submitted applications
Keep an eye out in your inboxes for the go live email!
If you would like to discuss how Fusion Pharma can support you, please email us at hello@fusion-pharma-limited.com or phone us on +44(0)203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
