南非传统药物注册监管指南制定建议
Recommendations for the development of regulatory guidelines for registration of traditional medicines in South Africa.
作者信息
Ngcobo M, Nkala B, Moodley I, Gqaleni N
机构信息
Traditional Medicine Laboratory, Department of Occupational & Environmental Health, Nelson R Mandela School of Medicine, University of KwaZulu-Natal Durban, South Africa.
出版信息
Afr J Tradit Complement Altern Med. 2011 Oct 2;9(1):59-66. doi: 10.4314/ajtcam.v9i1.9. eCollection 2012.
Abstract
The regulation and registration of traditional medicines (TM) continues to present challenges to many countries regardless of the fact that an increased number of the population utilises TM for their health care needs. There have been improvements in the legal and policy framework of South Africa based on the WHO guidelines. However, there are currently no guidelines or framework for the registration of TM in South Africa. This article reviews literature and existing guidelines of specific countries and regions and makes recommendations for South African guidelines.
摘要
尽管越来越多的人将传统药物用于医疗保健需求，但传统药物的监管和注册对许多国家来说仍然是一项挑战。基于世界卫生组织的指导方针，南非的法律和政策框架已有改进。然而，目前南非尚无传统药物注册的指导方针或框架。本文回顾了特定国家和地区的文献及现有指导方针，并为南非的指导方针提出建议。
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