Closing regulatory gaps: new ground rules for platelet-rich plasma

被引：28

作者：

Anitua, Eduardo ^{[1
,2
]}

Prado, Roberto ^{[2
]}

Orive, Gorka ^{[1
,2
]}

机构：

[1] Eduardo Anitua Fdn Biomed Res, Vitoria, Spain

[2] BTI Biotechnol Inst, Vitoria, Spain

来源：

TRENDS IN BIOTECHNOLOGY | 2015年 / 33卷 / 09期

关键词：

platelet-rich plasma; regulatory framework; medicinal product; PRODUCTS; MEDICINE; THERAPY;

D O I：

10.1016/j.tibtech.2015.07.002

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 [微生物学]; 090105 [作物生产系统与生态工程];

摘要：

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.

引用

页码：492 / 495

页数：4

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