Regulatory Development on Marketing Authorization of Herbal Products in Thailand

Abstract

The objective of this research was to develop the regulation on marketing authorization of herbal products in Thailand for preparing the subordinate laws according to the   Herbal Products Act B.E. …. .  Documentary research and qualitative research were used in this study.  Documentary research was used by reviewing and comparing the marketing authorization system of herbal products in the selected countries. i.e., United States of America, Japan, Australia, Singapore, Malaysia, Thailand, European Union and ASEAN countries.  The results showed that there was diversity of the marketing authorization system of herbal products in the selected countries including the term used, classification and submission procedures depending on the laws and regulatory systems in each country.  The draft version of the regulation on marketing authorization of herbal products in Thailand was prepared by modifying from the system of those selected countries.  After that, qualitative data was collected through focus group discussion of the draft version. The result of focus group discussion was used to develop the final version of the regulation on marketing authorization of herbal products in Thailand, consisting of the followings: 1.) Classification of herbal products. i.e., herbal medicinal products and herbal health supplement products 2.) Classification of indications or health claims of herbal products based on the risk levels. i.e., low, intermediate and high risk 3.) Categorization of herbal products which the manufacture or import for sale must have notification certificate or notification of details certificate or registration certificate 4.) Other items that must be submitted in the notification or notification of details or registration.