Traditional therapies based on plant medicines have been documented in great detail and are used globally. The development of novel medicines is embedded in different regulator systems. The variable status of ‘herbal medicines’ is equally complex as it is evident already from the complex terminology like listed as
medicines (Australia),
herbal medical products (European Union),
botanicals (USA), or
natural health products (Canada). These systems are either defined at a national level, like in India, China, and the USA, or they cover a region (group of countries), like the European Union or the Americas where people depend on medicinal plants but it is dispersed among different ethnic groups. Researchers are required to follow the regulatory requirements of the country/region where they wish to develop/use a product. However, for many of these systems, the regulatory framework is weak both in terms of their legal basis and enforcement.
This Research Topic focuses on the impact of these complex regulatory frameworks and their interpretations on the development of novel herbal medical products. Such developments may not focus on medicine (drug) development as such, but the aim may also be to market these products as cosmetics, supplements, or even foods. Simplified procedures are commonly used for herbal medicinal products considered to be safe. For example, in India, “phytopharmaceuticals” can be registered based on simplified clinical trials.
In this Research Topic, the focus is on regulatory science and on what is needed in terms of R&D in this context. We encourage primary reports and reviews on the context of regulation and herbal medicine development, including:
• Pre-clinical studies and clinical trials on the activity in the context of registering/licensing a medicine of plant origin.
• Safety is often a hallmark of these research and development strategies, and, therefore, analysis of the implementation of such safety assessments will be welcome.
• Regulatory requirements for drug development from plant origin especially in the context of changing national legislations and on a comparative basis between countries and regions.
• Assessments of the evidence base required for such regulated products.
Topic Editor Dr Chandrakant Katiyar is the CEO of Emami Ltd (India). All other Topic Editors declare no competing interests with regards to the Research Topic subject.---
All the manuscripts submitted to the collection will need to fully comply with the
Four Pillars of Best Practice in Ethnopharmacology (you can freely download the full version
here).
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