How to use the procedure for medicines licensing applications.
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Isotretinoin – changes to prescribing guidance and additional risk minimisation measures
The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. We ask healthcare professionals to review these new measures and supporting materials and integrate them into their clinical practice.
MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form of lung cancer
As with all products, we will keep its safety under close review
Fake Mounjaro (tirzepatide) KwikPen 15mg pre-filled pens
Fake medicines are illegally produced products that may contain incorrect ingredients, no active ingredients, or harmful substances.
Electronic Common Technical Document (eCTD) submissions update
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.
Aurum pre-filled syringes phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible needle-free connectors to minimise the risk of syringe blockage (DSI/2025/02)
Due to a phased introduction of the new 10ml CONNECT barrel design for the Aurum pre-filled syringes, the range of compatible needle free connectors (NFCs) differs between the established syringe barrel and the new syringe barrel. It is vital that healthcare professionals use compatible NFCs with Aurum pre-filled syringes to prevent delays to delivery of emergency medication.
Field Safety Notices: 12 to 16 January 2026
List of Field Safety Notices from 12 to 16 January 2026.