Alzhrani Riyad F, Fitahi Rawan A, Majrashi Majed A, Zhang Yu, Maniruzzaman Mohammed
Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, 11451, Saudi Arabia.
Bioengineering Institute, King Abdulaziz City for Science and Technology (KACST), Riyadh, Saudi Arabia.
Drug Deliv Transl Res. 2025 Sep 16. doi: 10.1007/s13346-025-01966-x.
The commercialization of additive manufacturing (AM) in pharmaceuticals manufacturing has attracted significant attention for its potential to produce customized products. However, the process is slow and hindered by the lack of designated regulatory guidelines tailored to 3D-printed pharmaceutical products (3DPPs). The 3D-printing technology has paved the way for personalized medicine, enabled treatment of rare genetic disorders, and offered many other possibilities for patients. Despite the US Food and Drug Administration (FDA) approval of Spritam, a clear regulatory framework for licensing 3DPPs by the FDA or EMA remains unavailable. The current practice considers all products the same, regardless of their manufacturing method and/or complexity. While this approach has been generally accepted, it frequently fails to evaluate the unique quality attributes of 3DPPs. The lack of a harmonized regulatory framework tailored to the 3DPPs presents a major barrier to the widespread adoption of AM and other innovative technologies. To bridge this gap, this review highlights the most critical parameters related to the feedstock materials and 3D-printing processes, emphasizing their impact on the quality attributes of finished 3DPPs. Numerous scenarios have been proposed to encourage regulatory authorities to establish robust regulatory guidance for the 3D-printing technology at either industrial or point-of-care (PoC) settings. Coordinated efforts between regulatory authorities, industry partners and other stakeholders are necessary to define product specifications and identify appropriate analytical techniques for evaluating finished 3DPPs. By developing a harmonized regulatory framework and establishing quality control measures, the full potential of AM can be realized. This will ultimately ensure that novel 3DPPs and personalized medicines adhere to rigorous regulatory standards of quality, safety and efficacy.
增材制造（AM）在药品生产中的商业化因其生产定制产品的潜力而备受关注。然而，该过程进展缓慢，且因缺乏专门针对3D打印药品（3DPPs）的监管指南而受阻。3D打印技术为个性化医疗铺平了道路，能够治疗罕见遗传病，并为患者提供了许多其他可能性。尽管美国食品药品监督管理局（FDA）批准了速溶片（Spritam），但FDA或欧洲药品管理局（EMA）尚未出台明确的3DPPs许可监管框架。目前的做法对所有产品一视同仁，无论其制造方法和/或复杂程度如何。虽然这种方法已被普遍接受，但它常常无法评估3DPPs的独特质量属性。缺乏针对3DPPs的统一监管框架是AM和其他创新技术广泛应用的主要障碍。为了弥合这一差距，本综述重点介绍了与原料材料和3D打印工艺相关的最关键参数，强调了它们对最终3DPPs质量属性的影响。已经提出了多种设想来鼓励监管机构针对工业或即时护理（PoC）环境下的3D打印技术制定强有力的监管指南。监管机构与行业合作伙伴及其他利益相关者之间的协调努力对于确定产品规格和识别评估最终3DPPs的适当分析技术是必要的。通过制定统一的监管框架并建立质量控制措施，可以实现AM的全部潜力。这最终将确保新型3DPPs和个性化药物符合严格的质量、安全和疗效监管标准。
