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.
The MHRA is the first Regulatory body in the world to authorise a Crispr-based gene therapy.
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.
After Brexit the MHRA had been preparing to take over the role of sole approver of newly licensed medicines in the UK until now.
At the recent MHRA GDP Symposium held in February the inspectorate announced a change to the MHRA inspection process.
Anyone who has recently reviewed the Medicines and Healthcare products Regulatory Agency (MHRA) CMS may have noticed the notification at the bottom of the search page regarding GMP and GDP Certificates, stating the following
