Welcome
Welcome to the latest edition of MHRA News, our monthly newsletter for industry. 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.
To keep hearing from us with future editions, register here.
Clinical trials and investigations performance
Our 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 29 days and amendments completed within an average of 25 days. Clinical investigations also continue to be completed within statutory timeframes.
We have 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 the MHRA on legislative changes will be promoted when confirmed.
Established Medicines performance
We continue to take significant steps to assess applications for medicines approvals within statutory timeframes. As a result of steps taken, we have seen a notable increase in numbers granted from January to February, as we adapt to new ways of working. We can expect the median time to fluctuate as seen between January and February, which reflects our commitment to the prioritisation strategy.
The process change was introduced on 1 March 2024 to ensure applications are complete on initial assessment, or as soon after submission as possible. This new process change has the potential to reduce timelines substantially. The process change guidance is published alongside a webinar recording that runs through these changes.
In order to further improve the speed of our regulatory assessments, we request that, wherever possible, 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 MedTech regulatory reform
Laura Squire, our MedTech Regulations Reform Lead and Chief Officer for Healthcare Quality and Access, shared updates on progress towards the new regulatory framework in her March blog and a recent podcast.
A recording of our webinar about the future core regulations, hosted on 5 March 2024, has been published on the implementation webpage and contains an update on our intentions regarding scope, classification of general medical devices and IVDs, essential requirements and information to be provided with medical devices.
 Through the new route to market in only 30 days
A new formulation for XGEVA (denosumab), used in adults for the treatment of bone cancer, was the first product to be authorised by via the new International Recognition Procedure (IRP). The product was authorised in just 30 days, providing UK patients with earlier access to this treatment thanks to international recognition.
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.
Our work to tackle ethnic and other biases in medical devices
Earlier this month, Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review was published.
Read our response to the review which sets out our commitment to act on the relevant recommendations for us to take forward as the UK’s independent regulatory agency.
Product approval announcements
We have continued work to publish announcements to coincide with the conclusion of regulatory assessments, delivering on a key objective as listed within our corporate plan to build public trust and understanding of our work.
These are issued simultaneously as outcomes are communicated to applicants, and we work in tandem with the company and across the health systems and health technology assessment bodies ahead of issuing press materials. Products we have recently communicated about include diagnostic tools for people with heart disease and prostate cancer; a treatment for ulcerative colitis that both NICE and the MHRA have simultaneously published their recommendations on, and a first anti-seizure medication to treat patients with rare epileptic seizure disorder.
 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 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 launches
We are delighted to confirm that the MHRA’s new RegulatoryConnect portal and its first services are now available for customers to log in and use.
RegulatoryConnect is a new IT system being developed by the Medicines and Healthcare products Regulatory Agency (MHRA) to modernise its existing regulatory IT systems and make our regulatory services more streamlined.
The RegulatoryConnect portal will provide greater transparency and visibility for regulatory assessments.
Log in using your existing MHRA Submissions credentials to track the status of applications and view live authorisation details, including the status of, and key data held against your existing licences.
Guidance on how to get started, navigating the platform, and understanding application statuses is also available here.
Case study: clinical trial authorisation for early breast cancer treatment
We are committed to providing predictable and reliable timelines for clinical trial authorisation applications, so that sponsors can plan their studies in the UK with confidence. Today we have published the first in a series of case studies illustrating how companies have successfully completed their clinical trial submissions. Read our case study on early breast cancer.
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.
To keep hearing from us with future editions, register here.
Stay connected
|
