Medical Device Regulatory Updates
Those companies manufacturing and handling medical devices should be aware that there are changes to the UK regulatory environment coming.
RegulatoryConnect The MHRA’s new ‘Front Door’
The MHRA have made the first release of their RegulatoryConnect service available which allows tracking of the submission status of product licence applications but will soon offer much more.
New Valproate safety measures
The Medicines and Healthcare products Regulatory Agency (MHRA) announced that from the 31st of January 2024 new regulatory measures have been implemented to ensure that the known harms associated with valproate use are reduced.
Casgevy
The MHRA is the first Regulatory body in the world to authorise a Crispr-based gene therapy.
Brief reflections on a Licence Based Inspection
Phew…..that was exhausting!!! I know that is a usual comment after an inspection but this was a two day (and two inspectors, a lead inspector plus a trainee) under the new Licence Based Inspection process.
MHRA new recognition routes to access to new medicines
After Brexit the MHRA had been preparing to take over the role of sole approver of newly licensed medicines in the UK until now.