Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; Bluepharma - Indústria Farmacêutica, São Martinho do Bispo, 3045-016 Coimbra, Portugal..
Faculty of Pharmacy, University of Coimbra, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; Bluepharma - Indústria Farmacêutica, São Martinho do Bispo, 3045-016 Coimbra, Portugal.
J Pharm Sci. 2022 Oct;111(10):2687-2713. doi: 10.1016/j.xphs.2022.07.015. Epub 2022 Jul 25.
Scientific and technological breakthroughs in the field of Nanotechnology have been a driving force throughout the development and approval of Non-Biological Complex Drugs (NBCDs). However, the fast-growing expansion of NBCDs and the emergence of their follow-on versions have brought with them several scientific, technological, and regulatory challenges. The definition of NBCDs is still not officially recognized by the regulatory authorities, and there is no dedicated regulatory pathway addressing the particular features of NBCDs and their follow-on versions. The lack of clear and consistent regulatory guidance documents in this field, as well as, the inconsistency across different regulatory agencies, impact negatively on the acceptance and enormous potential of these drug products. Patient access to high-quality NBCDs follow-on versions may be compromised by regulatory uncertainty resulting from the use of different regulatory approaches across the globe, as well as within the same class of products. Accordingly, there is a real need to develop a specific regulatory pathway compliant with the complexity of NBCDs and their follow-on versions or, alternatively, make better use of available regulatory pathways. The main goal of the review is to deeply investigate and provide a critical overview of the regulatory landscape of NBCDs and follow-on versions currently adopted by the regulatory authorities. The dissemination of knowledge and discussion in this field can contribute to clarifying regulations, policies, and regulatory approaches to complex generics, thereby filling regulatory and scientific gaps in the establishment of therapeutic equivalence.
在纳米技术领域的科技突破一直是推动非生物复杂药物（NBCDs）的开发和审批的动力。然而，NBCDs 的快速发展和后续版本的出现带来了一些科学、技术和监管方面的挑战。NBCDs 的定义尚未得到监管机构的正式认可，也没有专门的监管途径来解决 NBCDs 及其后续版本的特殊特征。该领域缺乏明确和一致的监管指导文件，不同监管机构之间也存在不一致，这对这些药物产品的接受度和巨大潜力产生了负面影响。由于全球范围内以及同一类产品中使用不同的监管方法，监管的不确定性可能会影响患者获得高质量的 NBCDs 后续版本。因此，确实有必要制定符合 NBCDs 及其后续版本复杂性的特定监管途径，或者更好地利用现有的监管途径。本综述的主要目的是深入研究和批判性地概述监管机构目前采用的 NBCDs 和后续版本的监管格局。该领域的知识传播和讨论有助于澄清复杂仿制药的法规、政策和监管方法，从而填补建立治疗等效性方面的监管和科学空白。
