 Welcome to the latest edition of MHRA News, our monthly newsletter for industry where we update you on our most recent activities.
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 The latest MHRA performance data shows that clinical trials applications continue to be handled within statutory timescales.
Regulatory assessments for clinical trials have been completed in an average of 28 days for initial assessments (within the statutory timescale of 30 days) and an average of 27 days for assessments of amendments (within the statutory timescale of 35 days).
We have now embedded improvements in processing clinical trial applications into standard working practice. We will continue to make enhancements to make it easier and faster for applicants to gain approvals and to ensure the UK remains a prime destination for clinical trials.
Our Notification Scheme, launched in October 2023, reduces the time to process applications by more than 50 percent, for those that meet the eligibility criteria. Register your interest.
More information about individual trial application status, is available by emailing clintrialhelpline@mhra.gov.uk.
We are seeking views from interested stakeholders on our proposals to update our statutory fees, to ensure we continues to recover our costs. Our fees are updated on a regular basis to ensure they continue to achieve full cost-recovery in line with HM Treasury guidance ‘Managing Public Money’. The consultation is open now, closing on 24 October 2024.
On 22 August 2024, we approved a product licence for the medicine lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, following a thorough review of the benefits and risks.
Lecanemab is the first treatment for Alzheimer’s disease licensed for use in Great Britain that shows some evidence of efficacy in slowing progression of the disease.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
"Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.
We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.
As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up."
As for any new medicine, this decision was made with expert scientific advice on the benefit risk of lecanemab from the Commission on Human Medicines (CHM), the government’s independent advisory body.
From 1 January 2025, the MHRA will be responsible for licensing all medicines on the market in Northern Ireland (NI) under a UK-wide licence. The new arrangements will make the supply of medicines to the UK market simpler and easier.
Just to remind you, there are three key areas of change to be aware of and to action where necessary:
To ensure patients in Northern Ireland can access the same medicines as the rest of the UK, a single marketing authorisation will cover the whole UK. A UK Product Licence (PL) will replace separate licences for Great Britain and NI.
2. Changes to labelling and packaging
Medicines for the UK market will need to display a ‘UK Only’ label or sticker on the pack to show that they are only for sale within the UK.
Companies must submit their updated artwork by 31 December 2024.
3. Changes to the Falsified Medicines Directive (FMD)
The EU Falsified Medicines Directive (FMD) will no longer apply in Northern Ireland, bringing Northern Ireland in line with GB.
Register for the Windsor Framework webinar
The first MHRA Windsor Framework webinar for industry will take place on 19 September 2024.
Take action now to be ready by 1 January 2025
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We have recently launched a formal pipeline and portfolio gathering process and guidance web page where we are encouraging all current and future Market Authorisation Holders (MAHs) for medicines to participate. This will allow us to build effective resource and expertise, resulting in applications being assessed with expert scientific rigour and within predictable timeframes.
To support MAHs in this process we are holding a Medicines Pipelines – MHRA’s new forecasting process webinar, which is being held from 14:00 – 15:30 (BST) on Thursday 26 September 2024. This will introduce this process whilst highlighting the expectations of industry and the benefits that will be realised for industry timeframes, patient access, and system colleagues.
We encourage you to review the guidance and complete the new medicines pipeline data collection process in advance of the webinar. There is also an opportunity to submit advance questions about the process via the webinar registration form.
You can write to us, email us or call us to get in touch with the MHRA. Find out how near the bottom of our homepage.
For any comments and feedback on this newsletter, please email: info@mhra.gov.uk.
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