Short Lecture “Regulatory considerations of herbal medicines. New focus for authorization as medical devices”

Background: In the last decade, there has been a global upsurge in the use of traditional medicine and complementary and alternative medicine in both developed and developing countries. This is one of the main reasons for reinforcing the surveillance of the safety, efficacy and quality control of traditional medicine, complementary and alternative medicines. Important articles concerning to the new initiative about herbal medicines as medical devices were evaluated.

Aims: The objectives of this work are to present the update of regulations of herbal medicines and to show the tools for the evaluation herbal medicines as medical devices.

Results: It is exposed some of regulations about herbal medicines, taking into account the classification of the products, modalities approved, clinical trials quality specifications among others. The WHO strategy for the development of herbal medicinal product is also showed concerning to the strength of the quality, safety and efficacy policy through reglamentation of products, practices and professionals, the importance of clinical trials in order to guarantee the safety, quality and efficacy of Natural Health Product and the main mistakes in Clinical Trials of natural products are explained. Another important result is related with the register of herbal medicines (syrup, tablet etc) as medical devices, these products are characterized by metabolomics techniques, and they have nonpharmacological action for therapeutic, some of these products will be shown. Conclusions: Herbal medicines take special considerations in this moment, for its properties. Drug Regulatory Authorities should ensure the quality, safety and efficacy of traditional medicines.

There is no conflict of Interest.

Publication History

Article published online:
12 December 2022

• Reference

• 1 Mattoli L, Burico M, Fodaroni G. et al. New frontier in pharmaceutical analysis. A metabolomic approach to check batch compliance of complex products based on natural substances. Journal of Pharmaceutical and Biomedical Analysis 2016; 126: 156-162