An ongoing project meant to support EU Member States in developing and strengthening their capacity for monitoring and control quality, safety and efficacy in the field of blood tissues and cell transplantation.
Specific aims of this project are meant to promote and facilitate 1) harmonisation of inspections, 2) authorisation and vigilance systems for blood, tissues and cells for human application, and 3) to increase inter-MS collaboration and confidence in each other’s inspection and vigilance programs.
Special focus will be given to the implementation of the Single European Code for Tissues and Cells according to the Directive 2006/86/EC.
WP4 will work on harmonising the two existing EU documents on SARE (Serious Adverse Reactions and Events) annual reporting (one for blood and one for tissues and cells), acknowledging the specificities of the ART sector. ESHRE is currently participating in the planned meetings.
WP5B has concluded the document “Principles for Competent Authorities for the evaluation and approval of blood, tissues and cells that have been prepared with newly developed and validated processes based on clinical follow up of recipients”. It has been submitted in June to the European Commission and the External Advisory Board for their evaluation.