基本药物与药品注册：斯里兰卡的经验
Essential drugs and registration of pharmaceuticals: the Sri Lankan experience.
作者信息
Weerasuriya K
机构信息
Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka.
出版信息
Bull World Health Organ. 1993;71(2):229-35.
Many factors influence the regulation of pharmaceuticals in a country. The essential drugs concept, formulated by the World Health Organization to assist developing countries in selecting appropriate drugs, also provides a basis for regulation. Sri Lanka has long regulated pharmaceuticals as part of its health policy. Over 70% of 3436 pharmaceutical product registrations were found to be drugs (or alternatives) named in the country's essential drugs list. This is despite the fact that product registrations are mainly for the private health care sector, and the list is for the state sector. The essential drugs concept therefore appears to have influenced the pharmaceuticals registered in Sri Lanka.
许多因素影响着一个国家对药品的监管。世界卫生组织制定的基本药物概念旨在帮助发展中国家选择合适的药物，这也为监管提供了基础。长期以来，斯里兰卡一直将药品监管作为其卫生政策的一部分。在3436项药品注册中，超过70%被发现是该国基本药物清单中列出的药物（或替代药物）。尽管药品注册主要面向私营医疗保健部门，而基本药物清单是针对国营部门的，但基本药物概念似乎对在斯里兰卡注册的药品产生了影响。
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