22.4 Adverse events and reactions - Haemopoietic progenitor cells

22.4.1: HTA Guide for the management of serious adverse events (SAEs) and reactions (SARs)

All licensed establishments must have a system in place for reporting, investigating, registering and recording information about serious adverse events (SAEs) and serious adverse reactions (SARs) which may influence the quality and safety of tissues and cells, and which may be associated with any licensable activity, as well as any SAR observed during or after clinical application which may be linked to the quality and safety of tissues and cells.

Further details can be found in the Human Tissue Authority (HTA) Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment.

22.4.2: WMDA reporting system

The World Marrow Donor Association (WMDA) maintains a voluntary central global reporting system to report Serious (Product) Events and Adverse Reactions (SPEARs).