Mangla Bharti, Kumar Pankaj, Javed Shamama, Pathan Tabish, Ahsan Waquar, Aggarwal Geeta
Department of Pharmaceutics, Institute of Pharmaceutical Research, GLA University, Mathura, India.
Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, UCSI University, Kuala Lumpur, Malaysia.
Nanomedicine (Lond). 2025 Aug;20(15):1911-1927. doi: 10.1080/17435889.2025.2533107. Epub 2025 Jul 14.
Over the past decade, nanomedicines have witnessed significant advancements, with various nanocarriers being introduced into clinical practice. Despite this progress, the absence of a well-defined regulatory framework presents major challenges for stakeholders in the pharmaceutical and healthcare industries. Challenges in biocompatibility, nanotoxicology, and regulatory oversight limit the clinical translation of nanomedicines. This review discusses the key challenges and emphasizes on the lack of clear and effective regulations in nanotechnology, which creates obstacles for manufacturers while also leaving legislators, medical practitioners, and the general public unable to properly assess the risk and safety measures associated with the nanomedicines. This review highlights the existing regulatory gaps by analyzing the clinical applications of nanomedicine, discussing the significance of regulatory frameworks. The barriers to the regulatory systems of various countries are compared to identify the multifaceted challenges associated with ensuring the safety and efficacy of nanomedicine interventions. The lack of consensus not only impedes the research and development (R&D) efforts in nanoparticle-based therapies but also affects the future adoption of nanomedicines. There is an urgent need to establish and implement a coherent and globally synchronized regulatory framework to facilitate the innovation and advancements of nanomedicines.
在过去十年中，纳米药物取得了重大进展，各种纳米载体已被引入临床实践。尽管取得了这一进展，但缺乏明确的监管框架给制药和医疗行业的利益相关者带来了重大挑战。生物相容性、纳米毒理学和监管监督方面的挑战限制了纳米药物的临床转化。本综述讨论了关键挑战，并强调了纳米技术缺乏明确有效的法规，这给制造商带来了障碍，同时也使立法者、医生和公众无法正确评估与纳米药物相关的风险和安全措施。本综述通过分析纳米药物的临床应用、讨论监管框架的重要性，突出了现有的监管差距。比较了各国监管体系的障碍，以确定与确保纳米药物干预措施的安全性和有效性相关的多方面挑战。缺乏共识不仅阻碍了基于纳米颗粒疗法的研发工作，也影响了纳米药物未来的应用。迫切需要建立和实施一个连贯且全球同步的监管框架，以促进纳米药物的创新和发展。
