EU Regulations on Herbal Medicines and their Impact on the Industry's Business
EU Regulations on Herbal Medicines and their Impact on the Industry's Business

Author(s): Oana Iuliana Rujoiu
Subject(s): EU-Legislation
Published by: Societatea de Stiinte Juridice si Administrative
Keywords: regulations; plant-based medicines; phytotherapy; economics; European Commission;
Summary/Abstract: The research focuses on the European Commission's regulations for herbal medicines marketing registration and its impact on its businesses. The following study uses empirical research, which includes the analysis of several articles and technical documents. The study will examine the European Commission's directives for standardizing herbal medicines' registration procedures on the European market. According to WHO, of the 500,000 species, only 22,000 plants are used in traditional medicine, while only 3,000 have been scientifically evaluated. These data highlight the need to simplify the registration procedure, allow the process to be streamlined, and launch on the European market as many herbal medicines as possible. The costs involved in herbal medicine manufacturing sum to between € 90,000 and € 140,000 for each medicine plant. A large part of the costs is generated by the clinical tests required for the product registration process. However, the simplified registration procedure exempts products that can prove a 15-30 year history of components usage in the European space.

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