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Tag: International Recognition procedure (IRP)


MHRA approves first drug via the new IRP in 30 days

XGEVA is the first product to be authorised by the regulator through the new International Recognition Procedure (IRP). The latest formulation of XGEVA (denosumab)...

MHRA’s new IRP goes live, developers of new medicines can now submit applications

The EC Decision Reliance Procedure (ECDRP) has been replaced by the new International Recognition procedure (IRP)  The Medicines and Healthcare products Regulatory Agency (MHRA) made...