Welcome
Welcome to the fifth edition of our monthly MHRA industry newsletter. We are committed to keeping you updated on what is going on at the MHRA and this newsletter is part of a broad effort to ensure transparency and communication. We continue work to promote MHRA News across the sector to drive engagement and registration.
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Clinical trials and investigations performance
The latest MHRA performance data shows that all regulatory assessments for clinical trials are being completed within statutory timeframes – with initial assessments within an average of 26 days and amendments completed within an average of 24 days. Clinical investigations continue to be completed within expected timeframes.
The MHRA has now eliminated backlogs in processing clinical trial applications and embedded improvements into standard working practice. We will continue to make enhancements with new legislative measures to make it easier and faster for applicants to gain approvals and to ensure the UK remains a prime destination for clinical trials.
We are collaborating across the clinical research sector to co-develop comprehensive new guidance, to support successful implementation of the new regulatory framework. Further opportunities to hear from MHRA on legislative changes will be promoted when confirmed.
Established Medicines performance
We are taking significant steps to assess applications for medicines approvals within statutory timeframes. We will always prioritise applications according to public health need. Current timescales for regulatory decisions for established medicines in January have reduced compared to December, for both national routes and reliance routes.
From 1 March 2024 we will be introducing a process change to ensure applications are complete on initial assessment, or as soon after submission as possible. Additional guidance on the process change will be updated on the website.
To improve the speed of our regulatory assessments, we request that eligible national Marketing Authorisation applications submitted before 1 January 2024 that are awaiting first assessment are converted from the national route to recognition pathways. Applicants should email MHRAEMreply@mhra.gov.uk to register interest in this option.
Progress towards med tech regulatory reform
Following publication of our roadmap for new and robust regulations for medical devices which sets out the route to deliver enabling regulations for medical devices in the UK, Laura Squire, our Med Tech Regulatory Reform Lead and Chief Officer for Healthcare Quality and Access, shares an update on our progress towards implementation as part of a new blog series.
Representatives from industry are invited to join our webinar on 5 March, with an update on the scope and essential requirements of the intended future core regulations.
 International recognition route to market
We have continued to revise guidance to support applicants preparing to take products through our new international recognition route to market, using questions received from companies to identify where further information would be helpful.
Applicants can also review our September and November 2023 webinars and the eligibility checker to advise on adoption of this new route.
To keep hearing from us with future editions,
Outcome of pilot to boost patient access to lifesaving new medical technologies
We are pleased to announce the eight innovative medical technologies selected for the Innovative Devices Access Pathway (IDAP) pilot scheme. The overall aim of IDAP is to enable and improve patient access to innovative and transformative medical devices, particularly in areas of unmet patient need, by providing an integrated and enhanced regulatory and access pathway for developers.
As part of a £10 million funding package for boosting access to medical technology, these eight innovative tech companies will be supported to bring their devices to market. It could help transform the way we treat some of the biggest causes of death and disability in the UK.
 International collaboration
We were delighted to host a series of meetings with the US Food and Drug Administration’s Commissioner. Find out more about the events and read our CEO June Raine’s reflections on the meetings and opportunities for this strong international partnership.
 Operational Information Sharing
We remind customers that from 1 January 2024 Marketing Authorisation applicants submitting relevant regulatory applications are able to provide consent to share operational information with cross-UK health system partners. Consent to share operational information will be requested during the submission process via the MHRA’s Human Medicines Portal.
Operational Information Sharing involves sharing estimated timelines with our health system partners, with the aim of minimising delays in patient access to new medicines.
 RegulatoryConnect self-service portal to launch in March
Last week we announced that the RegulatoryConnect portal and its first self-serve tools will be available to customers from Monday 25 March 2024.
The RegulatoryConnect portal will provide greater transparency and visibility for regulatory assessments and timelines. This first release will let you log-in using existing MHRA submission credentials and access a common portal, where you will be able to track the status of your application and see which stage it is at, and view live authorisation details including the status and key data about your existing licences.
RegulatoryConnect, formerly known as the Regulatory Management System, is a new IT system being developed by the MHRA to modernise its existing regulatory IT systems and make our regulatory services more streamlined.
More information on what you need to get ready to use this service will be available to users soon.
 Lord O’Shaughnessy talks to New Scientist about transforming clinical trials
James O’Shaughnessy, who conducted an independent review into clinical trials, commissioned by the UK Government (‘The Lord O’Shaughnessy review’), features in a recent New Scientist podcast. He talks about his independent review into clinical trials, and how the UK is responding to reinventing the country’s clinical trials system.
Describing the MHRA, he said:
“The [MHRA] are now performing at the level that they should have been. In addition, they have introduced new guidance that reduces the regulatory burden for less complex later stage trials. They've become more nuanced and more sophisticated in the regulatory approach that they take."
This podcast was sponsored by the Department of Business and Trade and the MHRA.
Get in touch
You can write to us, email us or call us to get in touch with the MHRA. Find out how near the bottom of this page.
For any comments and feedback on this newsletter, please email: engagement@mhra.gov.uk.
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