Food or Medicine? A European Regulatory Perspective on Nutritional Therapy Products to treat Inborn Errors of Metabolism.

Evaluating nutritional therapy products might reveal a justifiable need for a pharmaceutical product. A flowchart can facilitate systematically distinguishing products that function medication-like in the management of IEMs. Subsequently, finding and implementing appropriate solutions for these products might help improve the quality, safety and accessibility including reimbursement of treatment for IEMs. This article is protected by copyright. All rights reserved.