Human Tissue Authority publishes 2024/25 Annual Review

The Human Tissue Authority (HTA) has published its annual review for 2024/25, outlining regulatory activities and progress on its three-year strategy launched in July 2024.

The HTA conducted 223 inspections across healthcare establishments in 2024/25, maintaining its increased inspection target for the third consecutive year. The majority of inspections (69%) focused on Post Mortem and Human Application sectors, identified as areas of higher regulatory risk.

During inspections, the HTA identified 902 shortfalls, with 63% classified as minor. The authority worked with establishments to address these issues and improve standards. No major or critical shortfalls were found in the Research, Anatomy or Public Display sectors.

The HTA approved 1,115 living organ donations during the year, maintaining similar levels to the previous year. The authority also processed 303 licence variation requests in the Human Application sector, prioritising urgent cases to avoid delays in patient treatment.

The authority introduced enhanced security measures including unannounced inspections and Evidential Compliance Assessments in the Post Mortem sector. The HTA also updated guidance on pregnancy loss remains disposal after consultation with over 40 organisations.

The authority launched its new internal Regulatory Insight Model & Index (RIMI) tool in March 2025 to improve data analysis and risk assessment. A new People Strategy was also introduced to support workforce development.

The annual review demonstrates the HTA's ongoing work to regulate the safe and ethical use of human tissue whilst supporting innovation in life sciences.