Abstract
Platelet-Rich Plasma Therapies:In the Right Pathway to Find their Regulatory Niche The Spanish Agency of Medicines and Medical Devices (AEMPS) has recently regulated the use of platelet-rich plasma (PRP), that is,patient’s own plasma enriched in platelets and therefore in proteins and growth factors, as a human use drug. It is the first time that one regulatory agency worldwide categorizes these types of therapeutic therapies. According to AEMPS, PRP approaches cannot be considered as an advanced-therapy medicinal product. PRPs are classified as non-industrial biological medicines, being subjected to a strict regulation in terms of production, validation, efficacy and safety.
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