EMA updates guidelines for diabetes drugmakers

Tue, 03 Jul 2012
Pharmaceutical firms have received updated guidance from European Medicines Agency (EMA) regarding the development of new treatments for diabetes.

The recently published guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus, which updates the previous document from 2002, gives guidance on the clinical studies the EMA requires to support the authorisation of new anti-diabetes drugs.

It states that from the 15 November 2012, companies will need to provide more information on the long-term safety of such medications, including a new section on cardiovascular safety.

More specific and up-to-date information on children-based studies will be required, while the updated guideline also includes new sections on the prevention or delay of the onset of type 1 or type 2 diabetes, as well as the preservation of beta-cell function in type 1 diabetics. The EMA notes, however, that experience in these areas is limited.

Another change involves the temporary removal of the section on diabetes complications, which according to the European regulator still needs substantial revision.

It is hoped that the updated guidance, which was finalised by the Committee for Medicinal Products for Human Use (CHMP) and the Efficacy and Cardiovascular Working Parties, will lead to the development of safer drugs for diabetes and pre-diabetes patients, and thus improve public confidence in these products.
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