Parramón Teixidó, Carlos JavierRodríguez Pombo, LucíaBasit, Abdul W.Worsley, AnnaCañete Ramírez, CarmeÁlvarez Lorenzo, CarmenCabañas Poy, María JosepGoyanes Goyanes, Álvaro2025-07-152025-07-152025-05-09Parramon-Teixido, C.J., Rodríguez-Pombo, L., Basit, A.W. et al. A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care. Drug Deliv. and Transl. Res. (2025). https://doi.org/10.1007/s13346-025-01868-y2190-393Xhttps://hdl.handle.net/10347/42477The integration of 3D printing (3DP) technologies into personalized medicine manufacture at the point-of-care is garnering significant interest due to its potential to create tailored drug products with precise dosages and other unique attributes. Both preclinical and clinical studies have demonstrated promising outcomes, including pharmacokinetic bioequivalence, improved patient acceptability, enhanced adherence, and the ability to produce consistent, reproducible dosage forms with accurate drug distribution. Some compounding pharmacies around the world are already incorporating 3DP into standard practice for simpler therapeutic treatments. However, further clinical evaluation is required for more complex treatments, such as multi-drug polypills. Conducting clinical trials involving 3DP technologies presents several challenges, including navigating evolving regulatory frameworks, addressing ethical and legal concerns, and complying with new point-of-care manufacturing guidelines. Although regulatory agencies are beginning to adapt their policies to accommodate 3DP, the absence of a comprehensive framework still creates uncertainty for pharmacists and healthcare providers. This article explores the planning and execution of clinical trials involving 3D printed medicines, with a focus on regulatory barriers, patient recruitment, compliance, and the integration of specialized equipment and expertise. It also discusses the implementation of 3DP for personalized drug manufacturing within hospital settings and offers guidance for obtaining clinical trial approval from the Spanish Agency for Medicine and Health Products (AEMPS). By providing these insights and recommendations, this article aims to support international harmonization and facilitate the adoption of 3DP technologies in clinical trials globally.eng© The Author(s) 2025. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.o rg/licenses/by/4.0/.Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/3D printingRegulatoryPersonalized medicationsPaediatricsPrinted pharmaceuticals and formulationsQuality controljournal article10.1007/s13346-025-01868-yopen access