Comparative Analysis of the Regulations for the Marketing and Quality Control of Herbal Products Used for Health in France, Peru and West Africa
Traditional medicine is increasingly promoted worldwide as a tool to achieve universal access to healthcare. Herbal medicines have formed the basis of healthcare throughout the world and are still widely used, playing a major role in the international health market. However, several factors influence the potential quality of phytotherapy. The diversity of herbal medicines, their various uses and preparation methods, the pluralism in access to these treatments, and the variability in the chemical composition of raw materials depending on their environment are all critical elements. This study compares the regulatory frameworks and quality control practices for plant-based health products in six countries: Benin, Burkina Faso, Guinea, Mali, Peru and France. It also provides an overview of the market in these countries. To do so, we compiled and highlighted key information from WHO guidelines, national legal documents, public databases on product registration and markets, and conducted interviews with health organisation experts. The main findings indicate that West African countries face challenges related to regulatory enforcement and limited industrial and research capacity. In contrast, Peru experienced an initial surge in production following regulation in 1997 and gained international recognition for Amazonian plants, but saw a decline after the 2009 U.S.-Peru Free Trade Agreement due to more stringent standards. France, while notable for its pharmacopoeia, struggles to implement quality control given the high volume of dietary supplements available. Based on these comparative insights, the paper recommends a multidimensional approach: promoting stakeholder training in good practices, developing robust pharmacopoeias, facilitating dialogue between traditional and allopathic medicines, and building shared infrastructures for research and quality control. These strategies, informed by successful practices across countries, aim to support the safe and equitable development of herbal health products worldwide.
Authors
- Rokia Sanogo (ORCID: https://orcid.org/0000-0003-3908-0629)
- Valérie Jullian (ORCID: https://orcid.org/0000-0002-1675-9105)
- Billy Cabanillas (ORCID: https://orcid.org/0000-0002-5226-7650)
- Latifou Lagnika (ORCID: https://orcid.org/0000-0003-2942-9372)
- Nicolás Fabre (ORCID: https://orcid.org/0000-0001-5896-5700)
- Luz del Rosario Vega Ybanez
- E.S. Baldé (ORCID: https://orcid.org/0000-0001-7029-8680)
- M Carraz (ORCID: https://orcid.org/0000-0001-8538-1567)
- Mahamane Haïdara
- Mayar Luis Ganoza-Yupanqui (ORCID: https://orcid.org/0000-0002-6114-1451)
- Agnès Aubouy (ORCID: https://orcid.org/0000-0003-2265-4972)
- Ines Y. Castro-Dionicio
- Noufou Ouédraogo (ORCID: https://orcid.org/0000-0002-1566-8498)
- Rosario Rojas
- Sahar Traore
- Charlotte Dumondin
- Madjid Amoussa
- Moisés Mendocilla‐Risco
Institutions
- Université Joseph Ki-Zerbo (BF)
- Université Fédérale de Toulouse Midi-Pyrénées (FR)
- Universidad Peruana Cayetano Heredia (PE)
- Institut National de Recherche en Santé Publique (ML)
- National University of Trujillo (PE)
- Centre for Innovation in Regulatory Science (GB)
- Université d'Abomey-Calavi (BJ)
- Ministerio de Salud (BO)
- Pharmacochimie et Biologie pour le Développement (FR)
- Institut de Recherche Agronomique de Guinée (GN)
- Institut de Recherche pour le Développement (FR)
Publication Details
- Journal
- Tropical Medicine & International Health
- Published
- 2025-11-30
- DOI
- https://doi.org/10.1111/tmi.70061
- Citations
- 1
- Primary Topic
- Ethnobotanical and Medicinal Plants Studies
- Type
- article
- Field-Weighted Citation Impact
- 1.75
Funders
- Institut de Recherche pour le Développement