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.