After several years of work by the Cell Therapy Products Working Party (CTP WP), the European Pharmacopoeia Commission (EPC) adopted the new general chapter Cell-based preparations for human use (5.32) during its 181st session in March 2025. The new chapter will be published in Issue 12.2 of the European Pharmacopoeia (Ph. Eur.) in October 2025 and will enter into force on 01 April 2026.

This significant addition to the Ph. Eur. provides a comprehensive framework for the production and quality control of cell-based preparations, while offering the flexibility required to address the rapidly evolving nature of the field. While not legally binding, the chapter provides an extensive set of general requirements common to all cell-based preparations, together with four detailed sections outlining specific requirements for human haematopoietic stem cells, human chondrocytes, human limbal stem cells, and human mesenchymal stromal cells.

The adoption of Cell-based preparations for human use follows the successful implementation of the texts on gene therapy medicinal products. Prioritising both cell and gene therapy areas for 2023-2025, the EPC highlights its commitment to ensuring the standardisation of quality and safety for advanced therapy medicinal products in Europe and beyond.