The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 5th edition of the Guide to the quality and safety of tissues and cells for human application. The updated guide provides a comprehensive overview of the most recent advances in the field, as well as technical guidance on ensuring the quality and safety of human tissues and cells applied to patients. It is intended for healthcare professionals involved in all stages of the relevant activities, from identifying potential donors to the clinical application in patients and their follow-up.