Abstract
Consuming modern medicines with traditional herbs to treat and prevent diseases or even maintain health and well-being is common in different countries. Despite the high prevalence of this activity in Yemen, there is neither proper regulation that controls the production, standardization, quality control and use nor an appropriate system for herbal pharmacovigilance in Yemen. Yemenis prefer to use herbs before resorting to allopathic medicines, sometimes in concomitant or alternative to the allopathic medication. Most people believe that herbs are safe, though there are many side effects associated with herbal medicines. For the safe and effective use of traditional herbal medication, there should be a regulation from the official authorities that controls their preparation, selling, quality control, production, and monitoring of the side effects. The World Health Organization (WHO) stated a guideline for monitoring herbal safety within the current pharmacovigilance framework. However, monitoring and reporting the adverse effects of allopathic medicines in Yemen are limited, and the situation is more complicated and challenging for herbal medicines. The present article highlighted the challenges and provided recommendations for the application of effective herbal pharmacovigilance.