Table 4.

Summary comparison of herbal medicine (HM) classification factors under the different pathways in the drug regulatory authority systems of the UK, Germany, USA, United Arab Emirates (UAE) and Kingdom of Bahrain

Classification factors	Regulatory authority
	UK	Germany	USA	UAE	Kingdom of Bahrain
Presentation	If a claim to treat major health conditions is added, the product is classified as a medicine that requires MA If a therapeutic indication based on long-standing use is added, the product is classified as a medicine that requires THR THR products can only be presented as oral, external and inhalation preparations MA products may include any preparation type	If a claim to treat major health conditions is added, the product is classified as a medicine that requires MA If a therapeutic indication based on long-standing use is added, the product is classified as a medicine that requires THR THR products can only be presented as oral, external and inhalation preparations MA products may include any preparation type	For a product to be classified as a dietary supplement, only function and structure claims are allowed Products that include claims of treating, diagnosing, preventing or curing diseases are automatically classified as botanical drugs Dietary supplements are only allowed in oral preparations Botanical drugs can be presented in any preparation	Products that include medical claims are classified as HMs If a product uses traditional use claims, it is classified as a traditional HM Traditional HMs can be presented in an oral, topical and rectal formulations Only HMs can be presented in any preparation	Products that contain claims based on traditional use are classified as health products If a medical claim to cure, treat or prevent a disease is added on the label, the product is classified as a medicine with a vegetable substance Health products can only be presented as oral, topical and nasal formulations Medicines with a vegetable substance can be presented in any preparation
Purpose	If a product requires the supervision of a medical practitioner, or a medical prescription, the product is classified as a medicine that requires MA	If a product requires the supervision of a medical practitioner, or a medical prescription, the product is classified as a medicine that requires MA	Not specified	Not specified	Products that contain a substance that is supplied on a medical prescription is classified as a medicine with a vegetable substance

MA marketing authorisation, THR traditional herbal registration