Saraf Shailendra
University Institute of Pharmacy, Pt. Ravi Shankar Shukla University, Raipur, Chhattisgarh, India.
Pharmacogn Rev. 2012 Jul;6(12):154-60. doi: 10.4103/0973-7847.99950.
Traditional medicines that formed the basis of health care throughout the world since the earliest days of mankind are still widely used and have considerable importance in international trade. Recognition of their clinical, pharmaceutical, and economic value is still growing, although this varies widely between countries and therefore regulation of exploitation and exportation is essential, together with international cooperation and coordination for their conservation so as to ensure their availability for the future. World Health Organization and European Union issued the guidelines defined the basic criteria for the evaluation of quality, safety, and efficacy of herbal medicines with the goal of assisting national regulatory authorities, scientific organizations, and manufacturers in assessing documentation, submissions, and dossiers in respect of such products. 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. The present review highlights the status of different countries adopted various approaches to licensing, dispensing, manufacturing, and trading to ensure their safety, quality, and efficacy.
自人类早期以来，构成全球医疗保健基础的传统药物仍被广泛使用，并且在国际贸易中具有相当重要的地位。尽管各国对其临床、药学和经济价值的认可程度差异很大，但对其认可仍在不断增加。因此，对传统药物的开发和出口进行监管至关重要，同时还需要开展国际合作与协调以保护这些药物，确保其未来的可得性。世界卫生组织和欧盟发布了相关指南，确定了评估草药质量、安全性和有效性的基本标准，目的是协助各国监管当局、科学组织和制造商评估此类产品的文件、申报材料和档案。关于药用植物的立法控制并非围绕结构化控制模式发展而来。各国界定药用植物或草药或其衍生产品的方式各不相同。本综述着重介绍了不同国家采取的各种许可、配药、制造和贸易方式的现状，以确保这些传统药物的安全性、质量和有效性。
