Table 2.

Summary comparison of herbal medicine (HM) definition and its regulation pathways in the drug regulatory authority systems of the UK, Germany, USA, United Arab Emirates (UAE) and Kingdom of Bahrain

	Regulatory authority
	UK	Germany	USA	UAE	Kingdom of Bahrain
Definition	“A product is an herbal medicine if the active ingredients are herbal substances and/or herbal preparations only” “The herbal substance being processed can be reduced or powdered, a tincture, an extract, an essential oil, an expressed juice or a processed exudate” “A herbal preparation is when herbal substances are put through specific processes which include extraction, distillation, expression, fractionation, purification, concentration and fermentation”	“Herbal products are medicinal products which exclusively contain as active substances, either one or more herbal substances, one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations. Herbal substances are all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried form, but sometimes fresh” “Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system” “Herbal preparations are obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates”	“Botanical preparations consist of vegetable materials, which include plant materials, algae, macroscopic fungi, or a combination of these materials. Botanical preparations often have unique features, for example, complex mixtures, lack of a distinct active ingredient, and substantial prior human use” “Dietary supplement is a product other than tobacco intended to supplement the diet: a vitamin, a mineral, herbs or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or a combination of any of the aforementioned ingredients”	“Product derived from plant origin is a finished labelled medicinal product that contains as active ingredients aerial or underground parts of plants, or other plant materials or combinations thereof, where in the crude state or as plant preparations intended for prophylactic or therapeutic or other human health benefits” “Plant preparations are herbal ingredients present in a form other than the crude medicinal plant material including powdered plant material, balsams, dried and fluid extracts, tinctures, essential oils etc., prepared from plant material, and plant preparations obtained by fractionation, purification or concentration, without chemically defined isolated constituents regardless of whether or not its therapeutically active constituents have been identified”	“Herbal product contains as active substances herbal substances or herbal preparations, alone or in combination” “A herbal substance is whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried form but sometimes fresh” “A herbal preparation is obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates”
Registration pathways	THR (traditional use) with directive 2004/24/EC or MA (conventional) with directive 2001/83/EC	THR (traditional use) with directive 2004/24/EC or MA (conventional) with directive 2001/83/EC	Dietary supplement with DSHEA of 1994 (does not get registered) or Botanical drug with Federal Food, Drug and Cosmetic Act	THM (traditional use) or HM with Ministerial decree No. 3276/1997 for registration and re-registration of products derived from natural source	Health product (traditional use) with decree amendments by law No. (20) of 2015 or Medicine with vegetable substance with decree by law No. (18) of 1997

DSHEA Dietary Supplement Health and Education Act, MA marketing authorisation, THM traditional herbal medicine, THR traditional herbal registration