Guidelines for the Regulation of Herbal Medicines in the South-East Asia Region. Developed at the Regional Workshop on the Regulation of Herbal Medicines, Bangkok, 24-26 June 2003
(2004; 30 pages)


Traditional medicine and complementary/alternative medicine (TM/CAM) have been used, through the ages, in all countries of the WHO South-East Asia Region (SEAR). Many countries in this Region have extensive systems of TM within existing health services. In the rural areas of countries such as India, Indonesia, Nepal and Sri Lanka, a large proportion of the population use traditional medicines to meet their primary health care needs. Due to this long history, the roles of TM and its practitioners have been recognized by the governments in this Region, with national policies and regulations on TM being implemented in many of these countries.

Used as self-care or as an alternative form of treatment to conventional medicines, there is a large market and demand for medicinal plants and herbal products. Many countries in SEAR need expertise and guidance to develop national regulations and safety monitoring systems. According to the WHO global survey on the national policy and regulation of TM, there are three common difficulties and challenges: lack of information sharing; lack of safety monitoring for herbal medicines; and lack of methods to evaluate their safety and efficacy.

The objective of these guidelines is to propose to Member States a framework for facilitating the regulation of herbal medicines/products used in traditional medicine (TM). The proposed framework, which has a regional perspective, should help accelerate the establishment of appropriate mechanisms for registration and regulation of herbal medicines within SEAR, based on criteria for safety of use, therapeutic efficacy, quality control and pharmacovigilance. Traditional medicine involves not only the use of herbal medicines, but also use of animal parts and minerals. As herbal medicines are the most widely used of the three, and as the other types of materials involve other complex factors, this document will concentrate on herbal medicines.

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