Regulatory and legal challenges

[sumonasumonakha.t]

Lack of clinical studies
There has been limited scientific research in the West regarding Kampō remedies, partly due to the complex nature of traditional medicine, where treatments are highly individualized. Western clinical trials often require standardized treatments, while Kampō emphasizes personalized medicine. Bridging this gap while respecting Kampō’s individualized approach presents a major challenge to both the writers of content and the translators of it.

Herbal safety and dosage
Many Kampō treatment formulations contain multiple herbs, each with its own active compounds. cyprus mobile database The interactions between these herbs and their effects on the human body can be difficult to study using Western pharmacological models and equally difficult to express when translating from Japanese.


4. Regulatory and legal challenges
The regulatory framework governing herbal medicine and supplements varies significantly between Japan and Western countries. In Japan, Kampō medicines are recognized as part of the national healthcare system and are often prescribed by licensed physicians. In contrast, in most Western countries, herbal remedies are classified as supplements, meaning they are subject to less stringent regulation.




Differences in approval processes
Bringing Kampō medicine to the West requires the navigation of complex regulatory environments. If medicines are identified as dietary supplements, there are limits to the claims that can be made about their health benefits. Translators must be aware of the benefits they can and cannot claim.


Standardization and quality control
In Western countries, there is a need for rigorous quality control to ensure that Kampō herbs are safe, free from contaminants, and standardised in potency. It will always be difficult for both writers of content and translators to balance the precise and accurate rendering of information with the fundamental concept of Kampō that medications should be personalised.