EMA-raadplegingsprocedure: conceptrichtlijn voor klinisch onderzoek van geneesmiddelen bij de behandeling of preventie van diabetes mellitus

The European Medicines Agency has released for public consultation a draft guideline on on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus – Revision 2.

This guideline intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment or delay in onset / prevention of diabetes. The current revision refers mainly to an update of the safety section with respect to cardiovascular safety, but also updated guidance concerning e.g. treatment effects on diabetes complications, requirements for first line indications, high strength insulin preparations, definitions of hypoglycaemia and development of oral treatments for patients with type 1 diabetes.

The draft guideline is available by clicking here.

Comments should be provided using this template and sent to cvswpsecretariat@ema.europa.eu by 15/08/2018.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

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