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| 1 minute read

MHRA grants first medicine approval via the new International Recognition Procedure

For the very first time, the MHRA has a granted a UK marketing authorisation (UKMA) for a medicine through its new International Recognition Procedure (IRP). 

The IRP is intended to be an expedited route to obtaining a UKMA for applicants which already hold a medicines approval from a regulatory authority in a trusted country: Australia, Canada, the European Union, Japan, Switzerland, Singapore or the United States. 

The IRP replaced the European Commission Decision Reliance Procedure and Mutual Recognition/Decentralized Reliance Procedure. These procedures were essentially post-Brexit transitional arrangements that allowed the MHRA to grant a UKMA based on existing EU marketing authorisations. The IRP now allows the MHRA to grant UKMAs based on existing approvals from a far wider range of jurisdictions. In theory, this allows post-Brexit Britain to access medicines from across the world faster than it could as a member of the EU.

It remains to be seen whether this theory holds in practice. While the MHRA has now granted a UKMA through the IRP, and did so in just 30 days from application, that UKMA was granted for a simple new formulation (a pre-filled syringe) of an existing product (XGEVA, INN denosumab). The MHRA was not asked to rely on another regulator's assessment of any new clinical data concerning safety or efficacy. At the point where the MHRA is asked to rely on another regulator's assessment of such data, we may find the MHRA struggles to limit itself to a light touch review and the process slows considerably. 

And the authorisation from a trusted jurisdiction which the MHRA relied on in this case? An EU centrally authorised marketing authorisation issued by the European Commission. It will be interesting to see how the MHRA deals with an application through the IRP which is based on an authorisation granted in a more unfamiliar jurisdiction such as Australia or Japan.  

This new international agreement allows treatments to be approved more quickly by drawing on expertise from partners across the world, reducing bureaucracy and sharing resources so patients can benefit as soon as possible. XGEVA being approved quicker than usual is testament to this innovative approach.


mhra, marketing authorisation, international recognition, ema, xgeva, denosumab, medicines, biotech, brexit, life sciences, life sciences regulatory