Malaysian herbal monograph development and challenges
Terence Yew Chin Tan, June Chelyn Lee, Norsyaidatul Akmal Mohd Yusof, Bee Ping Teh, Ami Fazlin Syed Mohamed
Abstract
This paper aims to examine the development processes and challenges of the Malaysian Herbal Monographs (MHM) committees in developing herbal monograph. With increasing demand in the herbal market, efforts were made under the Agriculture National Key Economic Area to identify high-value botanical drugs and to contribute to the transformation of herbal products towards nutraceuticals. The MHM committees were established to streamline the development process of the monograph with the main activity of assisting the herbal industrial sector in their product preparations. The monograph publication process consists of selection, collection and processing of raw materials, identification tests, quality control (purity and safety testing) of herbal raw materials, safety information such as toxicity tests and efficacy related information such as traditional use and pharmacological actions of herbal plants. All the information and data gathered will be verified by the committees. This publication process involves collaboration between research institutes, government regulatory bodies, universities and other government agencies to be finally endorsed by the MHM committees for industry and public viewing. However, there are many challenges faced in key areas such as sustainability of raw materials, complexity of identification tests and a lack of well documented traditional data. Therefore, it is important to identify and overcome such key challenges, to support the development pathway from monograph to pharmacopoeia.