Current regulatory challenges and approaches in the registration of herbal drugs in Europe

N. Verma
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引用次数: 8

Abstract

Abstract Herbal medicines have formed the basis of healthcare worldwide since the earliest times and are still widely used. Recognition of their clinical, pharmaceutical, and economic value is still growing, although this varies widely between countries. Legislative controls in respect of medicinal plants have not evolved around a structured control model. There are different ways in which countries define medicinal plants or herbs or products derived from them, and countries have adopted various approaches to licensing, dispensing, manufacturing, and trading to ensure their safety, quality, and efficacy. The legal situation regarding herbal preparations varies from country to country. A critical problem in the evaluation of herbal drug products is the fact that they are complex mixtures of constituents and the constituents responsible for the therapeutics effects are unknown, which also complicates the stability of these products. A detailed literature survey of the current regulatory challenges and approaches in the registration of herbal drugs in Europe was performed to identify recently introduced changes in regulations or newly introduced regulations compliant with the regulatory bodies.
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当前欧洲草药注册的监管挑战和方法
自古以来,草药就构成了世界范围内医疗保健的基础,至今仍被广泛使用。对其临床、制药和经济价值的认识仍在增长,尽管各国之间差异很大。药用植物方面的立法控制尚未围绕一种结构化的控制模式发展。各国对药用植物或草药或其衍生产品的定义有不同的方式,各国在许可、配药、生产和贸易方面采取了各种方法,以确保其安全、质量和功效。关于草药制剂的法律情况因国家而异。草药产品评价中的一个关键问题是它们是成分的复杂混合物,而负责治疗效果的成分是未知的,这也使这些产品的稳定性复杂化。对当前欧洲草药注册的监管挑战和方法进行了详细的文献调查,以确定最近引入的法规变化或符合监管机构的新引入的法规。
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Changes to protocol in the regulation of adverse drug reactions – historical and current European view Policy and regulations in light of the human body as a ‘superorganism’ containing multiple, intertwined symbiotic relationships Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal Increasing the odds of effective drug development: Elevating regulatory affairs professionals to strategic partners Current regulatory challenges and approaches in the registration of herbal drugs in Europe
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