Nowadays, Herbal products are rapidly spreading throughout the world. These herbal products are used for various diseases in humans. The herbal medicines are available in various systems like Homoeopathic, Ayurvedic, Siddha, and Unani. Herbal medicines are derived from plant sources or plant parts. Herbal products are used to improve health, cure diseases, and increase immunity without having any side effects. Some herbal medicines are included in dietary supplements and in traditional medicine. It contains detailed information about the regulatory requirements and approval process of herbals in India and Europe. In India, the department of AYUSH under the Drugs and Cosmetics Act provides guidelines on quality, safety, and efficacy of herbal products. In India and Europe, the herbal guidelines were introduced to regulate the quality, nonclinical studies and clinical safety studies. India published a herbal pharmacopoeia to maintain quality herbal medicine. This comparison study helps to find the differences in regulatory requirements and approval process of herbal medicines in between different countries.