3D Printing of Pharmaceuticals: Quality Assurance Considerations and Regulatory Challenges

Abstract

Three-dimensional (3D) printing, also known as additive manufacturing, has emerged as a transformative platform in pharmaceutical science, creating unprecedented opportunities for personalized medicine and on-demand drug production. Tracing its origins to early photo-sculpture and topographical modelling techniques, 3D printing has since evolved into a versatile manufacturing approach capable of generating complex, patient-specific dosage forms. This review presents a comprehensive account of the historical evolution of 3D printing and its present-day applications in pharmaceutical drug delivery, with particular attention to inkjet-based, extrusion-based, and laser-based printing technologies. The advantages offered by 3D printing—including dose individualization, complex geometries that enable controlled drug release, decentralized manufacturing, and enhanced patient compliance—are critically examined. In parallel, key quality assurance considerations, such as raw material selection, process control, reproducibility, and product performance, are discussed in relation to the different printing modalities. The regulatory landscape governing 3D-printed pharmaceuticals is further analyzed, with emphasis on existing guidance, approval pathways, and gaps within the frameworks established by agencies such as the FDA, EMA, and NMPA. Despite its considerable promise, the broader adoption of pharmaceutical 3D printing continues to be constrained by challenges related to material availability, process standardization, intellectual property protection, and regulatory ambiguity. Overcoming these barriers through harmonized quality standards and adaptive regulatory policy will be essential to fully integrate 3D printing into routine pharmaceutical manufacturing.