A systematic review of 3D printing of pharmaceutical drug products: Barriers and enablers.

The transition of pharmaceutical 3D printing (3DP) from centralized production to decentralized, point-of-care (POC) settings presents complex regulatory and operational challenges. This systematic review synthesizes these barriers and evaluates the adaptability of emerging governance frameworks. A PRISMA-compliant systematic search was conducted up to June 2026 across five databases. Sixty-four eligible articles underwent inductive thematic analysis to identify recurring patterns regarding regulatory, technical and practical implementation factors. Ten descriptive themes were identified. The three most prevalent, accounting for most of the academic discourse, were Quality Control and Quality by Design (22%), Regulatory Gaps and Uncertainty (16%), and Ethical, Legal and Social Considerations (14%). To bridge the gap where technological maturity currently outpaces regulatory infrastructure, a four-phase integrated operational roadmap is proposed, synthesizing global regulatory initiatives. The developed roadmap could contribute to the scaling of 3DP into mainstream healthcare supporting alignment of policy reforms with operational readiness.