The herbal medicine industry has experienced remarkable growth over recent decades.
The herbal medicine industry has experienced remarkable growth over recent decades. However, without well-defined legal and regulatory frameworks, this growth can pose a threat to public health and lead to the failure of emerging businesses. Full understanding of legal requirements, regulatory processes, and licensing procedures is a fundamental prerequisite for entering and succeeding in this specialized market.
Unlike supplements or cosmetics, herbal medicines are directly related to human health. Therefore, official regulatory bodies—such as the Food and Drug Administration (FDA) in the U.S. or the Food and Drug Organization under Iran’s Ministry of Health—have implemented strict rules to assess the quality, safety, and efficacy of such products.
To bring an herbal medicine product to market, several essential steps must be completed:
Startups must initially obtain research and preclinical testing permits from authorized regulatory institutions before beginning product development.
Comprehensive data must be compiled regarding formulation, dosage, toxicity profile, and mechanism of action. These should be documented in standard formats required by regulatory bodies.
The production process must comply with GMP (Good Manufacturing Practice) standards and remain under the supervision of regulatory agencies throughout.
Herbal product labels must include accurate and complete information such as ingredients, usage instructions, warnings, expiration date, license number, and manufacturer’s details.
Once documentation and quality control tests are approved, the product must be officially registered in national systems. Only then can it be legally distributed to pharmacies or exported to international markets.
Early-stage startups often lack full understanding of the legal and regulatory landscape. In this journey, health-focused accelerators and regulatory/legal consultants play a vital role in expediting procedures and minimizing risks.
Major challenges in this process include complex documentation, high testing costs, and varying regulatory standards across different countries. However, gaining knowledge in this area and collaborating with reliable regulatory bodies can open major opportunities for global branding and export development.
Understanding herbal medicine regulations is not just a legal obligation—it is a competitive advantage. Companies that build their processes on solid documentation and regulatory alignment from the beginning are more likely to achieve sustainable growth and successful exports.
