Implementing printing technology in hospital pharmacy preparation – an interview study on opportunities and challenges from medicines authorities’ perspective

Advances in three-dimensional (3D) printing technologies have created new possibilities for pharmaceutical manufacturing in hospital setting. One of the key attributes of various 3D printing methods is their capacity for customisation, which benefit patients who require individualised doses and dosage forms. However, the regulatory landscape in Europe regarding 3D printing of pharmaceuticals remains unclear. This study aimed to (1) survey the perceptions of European medicines authorities regarding the implementation of 3D printing technology in hospital setting, (2) assess the manufacturing process and quality considerations that influence the adoption of the new technology from regulatory standpoint and (3) examine practical collaboration models between hospital pharmacies acting as dosage form manufacturers and pharmaceutical companies acting as suppliers of equipment, material, intermediate and/or product and process development. A subset of European medicines authorities (n = 5/27) participated in semi-structured interviews, which were guided by three predefined scenarios describing potential approaches to implementing 3D printing in hospital settings. The collected data were analysed using qualitative content analysis. 3D printing was seen as a transformative advancement in pharmaceutical manufacturing. The potential in the production of personalised medicine was identified as a valuable opportunity, whereas the primary concerns pertained the safety and quality of 3D printed pharmaceuticals. Despite the challenges in recruiting the participants, this research highlights the need for more explicit regulatory guidelines and measures to establish robust quality control that ensure the safety and efficacy of the finished products.