Regulatory requirements for the development of medicinal products for Acute Kidney Injury (AKI) - Scientific guideline

The concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.

Keywords: Acute kidney injury, renal failure, development

Current version

Reflection paper on regulatory requirements for the development of medicinal products for Acute Kidney Injury (AKI)

AdoptedReference Number: EMA/CHMP/536854/2023

Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury

Consultation dates: 30/07/2018 to 01/08/2019Draft: consultation closedReference Number: EMA/CHMP/171100/2018 Corr.Summary:

The concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.