3D printing of medicines: regulatory and quality perspectives

Conventional "one-size-fits-all" industrially manufactured medicines often fail to meet the specific therapeutic needs of vulnerable or minoritarian populations, such as the pediatric and geriatric patients. While traditional compounding addresses these gaps, it faces significant quality, scalability, and standardization limitations. Three-dimensional (3D) printing has emerged as a transformative additive manufacturing technology, enabling the precise, layer-by-layer fabrication of personalized oral dosage forms. This review comprehensively analyzes the regulatory landscape, quality requirements, and recent clinical advances of 3D printed pharmaceuticals. At the industrial level, 3D printing demonstrates compatibility with existing Good Manufacturing Practices (GMP) and conventional regulatory pathways, as evidenced by U.S. Food and Drug Administration -approved and late-stage clinical products. Conversely, decentralized point-of-care manufacturing within hospitals and pharmacies currently lacks a specific, harmonized regulatory framework. However, an increasing number of clinical trials, particularly focusing on dose-sensitive pediatric therapies, and the introduction of novel decentralized regulatory models highlight its clinical viability. In conclusion, while pharmaceutical 3D printing is reaching technological maturation, traditional quality guidelines must be updated to address its unique digital attributes. Collaborative efforts between regulators, academia, and industry are crucial to successfully implement 3D printing into routine personalized healthcare.