Revision to EMA Alzheimer’s Trial Guideline

The European Medicines Agency Guidelines on the clinical investigation of medicines for the treatment of Alzheimer's Disease (AD) were last updated in 2018. The Agency has recently published a concept paper concerning future revision of these Guidelines.

‍ The revisions are, in part, the result of recent advances in the field of AD, including the recent authorisation in the EU of a medicinal product for treatment of early-stage Alzheimer's Disease (AD) by targeting amyloid plaques, and experience from several marketing authorisation applications for early AD treatments. The Concept Paper includes proposals to include identified elements that would be “helpful in designing state of the art clinical trials in AD, including early AD, and enhancing drug development in the field.when developing clinical trials”. The EMA plans to release a draft CHMP guidance document for consultation not later than Q4 2026.

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