Salako L
Nigerian Institute of Medical Research, Lagos, Nigeria.
Med Trop (Mars). 1998;58(3 Suppl):82-4.
In many African countries, the first step for introducing a new drug is its selection on the Essential Drug List (WHO) according to the need, the efficacy, the safety, and the affordability of the product. Requirements for registration of artemisinin and its derivatives are either simple notification or authorization, or full registration. Procedures may vary from country to country, depending upon the level of development of their national regulatory system. The availability of mechanisms to regulate the distribution and the use of these new antimalarials are also depending upon the availability of manpower to implement them. The only artemisinin derivative which has been evaluated clinically in Africa and registered in some African countries, for the treatment of severe and complicated malaria, is intramuscular (i.m.) artemether. The major advantage of artemether is that it is given i.m., thus can be used at peripheral facilities where treatment with intravenous infusions of quinine would not be possible. Post registration surveillance, while being a component of the drug policy of some African countries, has not yet been adequately managed.
在许多非洲国家，引进一种新药的第一步是根据产品的需求、疗效、安全性和可承受性，将其列入基本药物清单（世卫组织）。青蒿素及其衍生物的注册要求要么是简单通报或批准，要么是全面注册。程序可能因国家而异，这取决于其国家监管系统的发展水平。规范这些新型抗疟药物分发和使用的机制是否可用，也取决于实施这些机制的人力是否充足。唯一一种在非洲进行过临床评估并在一些非洲国家注册用于治疗重症和复杂疟疾的青蒿素衍生物是肌肉注射蒿甲醚。蒿甲醚的主要优点是通过肌肉注射给药，因此可在无法进行静脉输注奎宁治疗的基层医疗机构使用。注册后监测虽然是一些非洲国家药品政策的一个组成部分，但尚未得到充分管理。
