Mudyiwenyama Linda G, Khoza Star, Dube Admire
School of Pharmacy, University of the Western Cape, Bellville, South Africa.
Front Med (Lausanne). 2023 Apr 20;10:1098830. doi: 10.3389/fmed.2023.1098830. eCollection 2023.
Medical products incorporating nanoparticle drug delivery systems (nanomedicines) are therapeutic or imaging agents, which comprise a delivery system within the nanometer size range (1 - 1000 nm). As medical products, nanomedicines meet definitions of medicines according to various national legislations for regulation of medicines. However, for the regulation of nanomedicines, additional assessments including toxicological issues have to be considered. These complexities require extra regulatory effort. In the resource-limited context of low- and middle-income countries, many National Medicines Regulatory Authorities (NMRAs) lack resources and capacities to effectively assure the quality of medicinal products in their countries. With emerging trends in innovative technologies, including nanotechnology, this burden is worsened. The need to overcome regulatory challenges drove the formation of a work sharing initiative in the Southern African Development Community (SADC), ZaZiBoNA in 2013. Regulatory agencies participating in this initiative cooperate in the assessment of applications for registration of medicines.
A cross-sectional exploratory study design with qualitative techniques was used to investigate the status of the regulation of nanomedicines in Southern African countries in particular those participating in the ZaZiBoNA initiative.
The study found that in general, NMRAs are aware of the existence of nanomedicines and they apply legislation applicable to other medical products. The NMRAs however neither have specific definition for nanomedicines and technical guidance documents, nor technical committees specific for consideration of nanomedicines. Collaboration with external experts or organisations in the regulation of nanomedicines was also found to be lacking.
Capacity building and collaboration in the area of regulation of nanomedicines is strongly encouraged.
包含纳米颗粒药物递送系统的医疗产品（纳米药物）是治疗或成像剂，其包含纳米尺寸范围（1 - 1000纳米）内的递送系统。作为医疗产品，纳米药物符合各国药品监管立法中对药品的定义。然而，对于纳米药物的监管，必须考虑包括毒理学问题在内的额外评估。这些复杂性需要额外的监管努力。在低收入和中等收入国家资源有限的情况下，许多国家药品监管当局（NMRA）缺乏资源和能力来有效确保本国药品的质量。随着包括纳米技术在内的创新技术的兴起趋势，这一负担更加严重。克服监管挑战的需求促使南部非洲发展共同体（SADC）在2013年发起了一项名为ZaZiBoNA的工作共享倡议。参与该倡议的监管机构在药品注册申请评估方面开展合作。
采用具有定性技术的横断面探索性研究设计，调查南部非洲国家，特别是参与ZaZiBoNA倡议的国家中纳米药物的监管状况。
研究发现，总体而言，国家药品监管当局了解纳米药物的存在，并且适用适用于其他医疗产品的法规。然而，国家药品监管当局既没有纳米药物的具体定义和技术指导文件，也没有专门审议纳米药物的技术委员会。在纳米药物监管方面与外部专家或组织的合作也很缺乏。
强烈鼓励在纳米药物监管领域开展能力建设与合作。
