Table 3.
Summary comparison of herbal medicine (HM) main registration requirements in the drug regulatory authority systems of the UK, Germany, USA, United Arab Emirates (UAE) and Kingdom of Bahrain
| Main registration requirements | Regulatory authority | ||||
|---|---|---|---|---|---|
| UK | Germany | USA | UAE | Kingdom of Bahrain | |
| Evidence of quality | GMP standards and QC tests for THR and MA | GMP standards and QC tests for THR and MA | Not required for dietary supplements GMP standards and QC tests for botanical drugs |
GMP standards and QC tests for traditional HMs and HMs Declaration of pork-free contents Declaration of alcohol content |
GMP standards and QC tests for health products and medicines with a vegetable substance Declaration of pork-free contents Declaration of alcohol content |
| Evidence of safety | Bibliographic data for THR Toxicological tests for MA |
Bibliographic data for THR Toxicological tests for MA |
Not required for dietary supplements unless it is a NDI Toxicological tests for botanical drugs |
Bibliographic data for traditional HMs Toxicological studies for HMs |
Bibliographic data for health products Toxicological studies for medicines with a vegetable substance |
| Evidence of efficacy | Long tradition of use for at least 30 years (including 15 years in the EU) for THR Clinical studies for MA |
Long tradition of use for at least 30 years (including 15 years in the EU) for THR Clinical studies for MA |
Not required for dietary supplements Clinical studies for botanical drugs |
Copies of at least two traditional HMs for each herbal ingredient for traditional HMs Clinical studies for HMs |
Copies of published scientific literature or international monographs for health products Clinical studies for medicines with a vegetable substance |
| Label requirement | For THR: must include a statement that the product is exclusively based on long-standing use Must include a certification mark (THR) |
For THR: must include the words “traditional medicines” and “traditionally used” | For dietary supplements: must include a disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease” Must state on the label that it is a dietary supplement |
No requirements | No requirements |
EU European Union, FDA US Food and Drug Administration, GMP Good Manufacturing Practice, MA marketing authorisation, NDI new dietary ingredients, QC quality control, THR traditional herbal registration