Quality control of medicinal agents derived from natural sources is
paramount in ensuring safety and efficacy. In the modern medical practice, the major
obstacles for the acceptance of herbal medicines are the lack of scientific and clinical
data on safety, quality and efficacy in herbal products. In general, there is no quality
control of medicinal products in many countries. Strict regulatory guidelines on herbal
products are followed only in few countries like Canada, Europe, Australia, the USA,
and Japan. In recent years, due to the enormous increased interest in herbal medicines,
we need strict regulatory guidelines to ensure safety and efficacy of herbal medicine.
The regulatory guidelines should focus mainly on laws related to the registration of
herbal medicines for manufacturing and marketing. This book chapter will provide a
comprehensive overview of a regulatory guidelines, required for manufacturing and
marketing of herbal medicines in regulated, semi-regulated and unregulated markets.
This book chapter also comprises discussion over global need of harmonization of
regulatory guidelines to ensure safe and effective use of herbal medicines.
Keywords: Efficacy, Herbal Medicines, Harmonization, Pharmacopoeia,
Regulatory Agency, Safety.
