 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 show that clinical trials and investigations applications continue to be handled within statutory timescales. Since September 2023, all clinical trial applications have been assessed within 30 days, with no backlogs.
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 28 days for assessments of amendments (within the statutory timescale of 35 days).
The MHRA has now embedded improvements in processing clinical trial applications into standard working practice. We will continue to make enhancements, and are introducing 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.
Further information about the regulatory reforms we are introducing to the UK’s clinical research sector will be published in the near future.
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
The latest MHRA medicines licence applications performance data shows that we continue to make significant steps towards assessing marketing authorisation applications for all medicines approvals within statutory timescales as our established medicines: marketing authorisation application changes take effect.
Our prioritisation strategy ensures that applications are taken in order of validation date, except for applications for products that can meet public health needs, for example to prevent shortages or first generic products.
For established medicines, this month we can report further progress in reducing our original backlog by 95% (concluding the assessment of 1109 out of 1167 applications). We have amalgamated the presentation of the data into one single reporting field to enable applicants to better understand our progress towards eliminating the small number of remaining overdue applications.
Our next licensing webinar is on 7 November at 11am and covers processes to manage medicines supply disruptions. This jointly presented webinar will provide an overview of how the healthcare systems work collaboratively to manage medicine supply to the benefit of patients. Secure your place and pre-submit your questions by registering via the webinar registration website.
We launched our new medicines forecasting process in August and delivered the supporting webinar in September. The medicines pipeline planning webinar recording is now available to view.
 The Windsor Framework (WF) agreement for medicines will be implemented on 1 January 2025. Patients in Northern Ireland will have access to the same medicines in the same packs, with the same labels, as the rest of the UK, making the supply of medicines to the UK market simpler and easier.
A recording of our first WF webinar is ready to view.
Three key areas industry needs to be aware of:
1. Labelling and packaging
All medicines for the UK will require a clearly legible ‘UK Only’ label on their packaging.
You must submit your updated artwork now to ensure you are ready by
1 January 2025.
2. Single licence UK-wide
A UK Product Licence will replace separate licences for GB and NI.
3. Falsified Medicines Directive (FMD)
The EU FMD will no longer apply in Northern Ireland.
If you are concerned about getting your updated packaging artwork to us on time, email partnerships@mhra.gov.uk and Include ‘WF implementation’ in the subject line.
For all other queries about labelling, e.g. adding ‘UK Only’, please contact us at: patient.information@mhra.gov.uk
 24 October 2024 was World Polio Day we highlighted our work by training multiple World Health Organisation (WHO) polio laboratories. Using an advanced molecular direct detection method that can halve detection times – supporting the global effort to eradicate polio and helping save lives.
The UK will be the first country in the world to introduce a tailored framework for the regulation of innovative products manufactured at or close to the location where a patient receives care.
Read the full release
The new legislation will introduce clearer and risk-proportionate requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers ahead of introducing the wider future regulatory regime.
Read the full release
In people with this disease, small fibres of TTR protein clump together to make deposits called ‘amyloid’. Amyloid can build up around or within the nerves, heart and other organs, stopping them from working properly.
Eplontersen is specifically indicated for use when the disease is causing polyneuropathy, which is damage to multiple nerves outside of the brain and central nervous system, resulting in pain, discomfort, progressive weakness and loss of sensation in the legs and arms, and mobility difficulties.
A full list of all side effects reported with this medicine is available in the patient information leaflet or from the product information published on the MHRA website.
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