Proposed Quality Control Guidelines for the EU Directive on Traditional Herbal Medicinal Products: Implications for Small- to Medium-Sized Enterprises

摘要

The European Union recently published draft quality-control guidelines applying to a new European Directive called the Traditional Herbal Medicinal Products Directive (THMPD). This Directive allows the licensing and over-the-counter sale of herbs thathave a history of use anywhere in the world for at least 30 years, 15 of which must be in an EU Member State. Implementing these quality control guidelines is likely to see companies incur significantly higher costs due to the additional requirements and complexities of product registration, labeling, and adverse-event reporting. This raises concerns that the costs for registration of products (especially those with mixtures of herbs) may be unattainable and uneconomic, resulting in reduction of both traditional herbal preparations and viable small- to medium-sized herbal companies. This is likely to mean fewer choices for consumers throughout the EU.