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.
MHRA inspection process
At the recent MHRA GDP Symposium held in February the inspectorate announced a change to the MHRA inspection process.
Update GMP and GDP Certificates
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
MHRA Guidance Note 6
MHRA Guidance Note 6 – Notes for applicants and holders of a Wholesale Dealer’s Licence (WDA(H)) or Broker Registration was updated in November 2022 with some significant changes regarding Brexit.