Resources » Guide for the Assessment of Clotting Factor Concentrates

Year: 2017

Language: English

This resource is also available in: Spanish

Author(s): Albert Farrugia

Format: Document

Guide for the Assessment of Clotting Factor Concentrates


The purpose of this guide is to inform and facilitate the selection and purchase of therapeutic products for the treatment of hemophilia.

It discusses the factors that contribute to the quality, safety, and efficacy of hemophilia treatment products and, in particular, the provisions made for ensuring that these products are free of viruses. It covers well-established systems in the United States and the European Union that regulate and control therapeutic products for hemophilia.

For regulatory agencies in countries without established systems, this guide provides guidance for the development of procedures, and offers a model for the evaluation of products, to ensure the safety and quality of therapeutic products for hemophilia.