纳米医学和管理科学:非洲的挑战

N. Z. Nyazema, J. T. Chanyandura, P. O. Kumar
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摘要

纳米技术发展中的综合方法正在允许将其引入多个领域,包括药物研究,其中现在有几种药物含有纳米材料,或者至少提出了基于纳米的声明。由于纳米技术研究的增加,已有的药物被重新配制,并且开发了新的药物。这给欧洲和美国目前的监管框架带来了挑战。众所周知,这些管理机构是严格的,因为它们既有人力能力和技能,也有有利的政策和环境来管理新技术,这与大多数非洲国家的机构不同。由于欧洲药品管理局(EMA)和美国食品和药物管理局(FDA)已经接受了监管科学(RS)作为一种对监管原则进行前瞻性分析的手段,这些机构将能够以一种直接的方式解决纳米医学的挑战。非洲国家目前没有统一的管理框架,因为不同的国家管理当局处于不同的发展水平。非洲的制药部门正面临许多挑战,包括产业界、大学和研究机构之间不存在促进纳米药物开发的研究与发展伙伴关系。既然非洲医药局已经成立,非洲应该迅速实施非盟《医疗产品条例示范法》,这将有助于在纳米医学RS方面实施能力建设方案。
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Nanomedicine and regulatory science: the challenges in Africa
The integrated approach in the development of nanotechnology is allowing its introduction into multiple fields, including pharmaceutical research, in which there are now several medicines containing nanomaterials or at least making nano-based claims. As a result of increasing research in nanotechnology, pre-existing medicines have been reformulated, and new medicines have been developed. This has brought challenges to the current regulatory frameworks in Europe and the United States. These regulatory agencies are known to be stringent because they have both the human capacity and skills and conducive policies and the landscape to manage new technology, unlike the agencies in most African countries. Because the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have embraced regulatory science (RS) as a means of proactive analysis of regulatory principles, those agencies will be able to address nanomedicine challenges in a straightforward manner. African countries currently do not have a harmonized regulatory framework because different national regulatory authorities are at different levels of development. The pharmaceutical sector in Africa is facing many challenges, including the non-existence of research and development partnerships between industry, universities, and research institutions that foster nanomedicine development. Now that the African Medicine Agency (AMA) is in place, Africa should see the rapid implementation of the AU Model Law on Medical Products Regulation that will assist in putting in place capacity-building programs in nanomedicine RS.
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