New Regulation A-9-2023-0250-AM-244-244_EN
This document contains the amendments proposed by the European Parliament to the Commission's regulation on standards of quality and safety for substances of human origin intended for human application.

This document contains the amendments proposed by the European Parliament to the Commission's regulation on standards of quality and safety for substances of human origin intended for human application.

A guideline document detailing the best practices for authorisation and preparation processes in blood, tissues, and cell establishments, including technical annexes for quality and safety assessments.

Detailed guidance on evaluating quality, safety, and efficacy of novel tissue and cellular therapies, offering methodologies and tools for best practices in tissue and cell preparations.

Comprehensive guide providing specific methodologies and tools for blood component preparation and quality assurance, co-funded by the European Union's Health Programme.