再生医学杂志

Platelet-Rich Plasma Therapies:In the Right Pathway to Find their Regulatory Niche

Eduardo Anitua, Roberto Prado1 and Gorka Orive

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.