The European Medicines Agency has updated its guidance for pharmaceutical companies developing medicines for the treatment or prevention of diabetes.
The guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus, published today, updates the previous document from 2002. It gives guidance on the clinical studies required to support the authorisation of new medicines for treating or preventing diabetes.
The main change to the guideline involves revision of the information on the long-term safety of anti-diabetes medicines, particularly the addition of a new section on cardiovascular safety. The update also involved inclusion of more specific and up-to-date information on studies in children.
New sections on the prevention or delay of the onset of type-1 or type-2 diabetes and on preservation of beta-cell function in patients with type 1 diabetes have also been added to the guideline, although experience in these areas is limited.
Because of the complexity of the update to this guideline, it went through two rounds of public consultation, one in 2010 and another in 2011. The Committee for Medicinal Products for Human Use (CHMP) and its Efficacy and Cardiovascular Working Parties took the comments received into account when finalising the document.
The section on complications of diabetes has been removed from the guideline for the time being, as it still needs substantial revision.
The updated guideline comes into effect on 15 November 2012.