Eduardo Anitua Foundation for Biomedical Research, Vitoria, Spain; BTI Biotechnology Institute, Vitoria, Spain.
BTI Biotechnology Institute, Vitoria, Spain.
Trends Biotechnol. 2015 Sep;33(9):492-5. doi: 10.1016/j.tibtech.2015.07.002.
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.
西班牙药品和医疗器械管理局（AEMPS）制定了一份全面的报告和决议，首次规范了富血小板血浆（PRP）作为人用药品的使用。这一监管框架为适应 PRP 使用的新的安全性和有效性要求带来了新的挑战。不同产品的异质性可能会阻碍其监管，而目前在不同的全球监管框架中，其监管存在很大差异。
