Herbal medicines have been used in traditional medical practices for centuries; however, the development of herbal medicine within an evidence-based medicine’s framework is relatively new. Demonstrating the safety and efficacy of such medicines is fraught with challenges and criticisms, especially when compared with “Western chemical medical compounds.” While practitioners of herbal medicine are often not only comfortable with the application of such medicines but also largely convinced by the results they experience with patients, the scientific validity of herbal medicines in research and development is still often questioned. This is partly due to the application of similar methodologies across dissimilar medical products as well as to a lack of quality control and product standardization.

The application of contemporary evidence-based approaches, particularly controlled clinical trials, has presented specific challenges and issues for herbal medicines in R&D. There is a need to follow the acceptable standards in the conduct of herbal medicine R&D, while also taking into account the complexity of the chemical composition of herbal medicines and their use in the framework of traditional medical practices. Research design and the conduct of research must be scientifically and ethically sound, while also accounting for the medical philosophies and practices that accompany the use of traditional medicines.

This Special Issue intends to identify current issues in herbal medicine development in different settings, to examine the methodological challenges, and to discuss the regulatory and ethical issues that arise, both in nonclinical and clinical research. The objective of this special issue is to examine the current state of the art for herbal medicines R&D while identifying appropriate methodologies to address issues and challenges for developing herbal medicine under the acceptable scientific and ethical standards.

Potential topics include but are not limited to the following:

• Current and prospective methodologies for testing herbal medicines in nonclinical and clinical settings
• Herbal product quality control and assurance
• Intellectual property
• Regulatory issues
• Ethical issues
• Informed consent in herbal medicine research
• Ethnopharmacology
• Nonclinical studies
• Clinical studies
• Data management issues
• Phytochemistry
• Drug formulation