title: Closing regulatory gaps: new ground rules for platelet-rich plasma.
abstract: The Spanish Agency of Medicines and Medical Devices (AEMPS) has drawn up a comprehensive report and resolution that regulates for the first time the use of platelet-rich plasma (PRP) as a human-use medicinal product. This regulatory framework offers emerging challenges to adapt the use of PRP to the new requirements of safety and efficacy. The heterogeneity of the different products can hinder their regulation, which today differs substantially in the different worldwide regulatory frameworks.
authors: Eduardo Anitua Foundation for Biomedical Research, Vitoria, Spain; BTI Biotechnology Institute, Vitoria, Spain. Electronic address: eduardoanitua@eduardoanitua.com.
authors: Eduardo
authors: E
authors: Anitua
authors: BTI Biotechnology Institute, Vitoria, Spain.
authors: Roberto
authors: R
authors: Prado
authors: Eduardo Anitua Foundation for Biomedical Research, Vitoria, Spain; BTI Biotechnology Institute, Vitoria, Spain. Electronic address: gorka.orive@fundacioneduardoanitua.org.
authors: Gorka
authors: G
authors: Orive
mesh_terms: D001709:Biotechnology / Q000331:legislation & jurisprudence*; D006801:Humans; D053657:Platelet-Rich Plasma; D013030:Spain
keywords: medicinal product; platelet-rich plasma; regulatory framework