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Herbal medicines have been used for centuries as natural remedies for various health issues. However, there are varying regulations across different markets for the use of herbal ingredients. The global trend of incorporating herbal ingredients in medicines is gaining traction across the globe, with the projected value of the global herbal medicine market reaching USD 411.2 billion by 2026.
The Association of Southeast Asian Nations (ASEAN) and Latin American (LATAM) regions are no exception to this trend, as there is a growing demand for natural and organic products in both these markets. However, the use of herbal ingredients in medicines is subject to varying regulations across different markets. In this blog, we shall explore the status of herbal ingredients in these two regions.
The ASEAN Region
The ASEAN region is a diverse market that includes countries such as Indonesia, Malaysia, the Philippines, Thailand, Vietnam, and others. The regulations for herbal medicines in the ASEAN region are still in their early stages, with different Regulatory frameworks in different countries. However, respective authorities are making efforts to harmonize regulations across the region.
In Indonesia, herbal medicines are regulated under the category of “traditional medicines” by the National Agency of Drug and Food Control (NADFC). To be approved as a traditional medicine, a product must be backed by scientific evidence that state its safety, efficacy, and quality. In Malaysia, herbal medicines are regulated under the category of “traditional medicines” by the National Pharmaceutical Regulatory Agency (NPRA). As per NPRA regulations, a product must be backed by scientific evidence highlighting its safety, efficacy, and quality in order to be identified as traditional medicine.
In the Philippines, herbal medicines are regulated under the category of “food supplements” by the Food and Drug Administration (FDA). Like Malaysia, here, too, the product must be supported by scientific proof of its safety, efficacy, and quality in order to be recognized as traditional medicine.
In Thailand, herbal medicines are regulated under the category of “traditional medicines” by the Thai FDA. As with the countries mentioned above, in Thaliand, too, a product must be supported by scientific evidence of its safety, efficacy, and quality in order to a be approved as traditional medicine.
LATAM Region
The LATAM region includes countries such as Brazil, Mexico, Argentina, to name a few. The Regulatory framework for herbal medicines in the LATAM region is more developed than in the ASEAN region since most countries have similar regulations.
In Brazil, herbal medications are regulated under the category of “phytotherapeutic medicines” by the Agência Nacional de Vigilância Sanitária (ANVISA), or the National Health Surveillance Agency/Brazilian Health Regulatory Agency. A product must be backed by scientific evidence to ensure its safety, efficacy, and quality in order to be approved as phytotherapeutic medicine.
In Mexico, herbal medicines are regulated under the category of “natural products” by the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), or the Federal Commission for Protection against Sanitary/Health Risk. For a natural product to be approved as herbal medicine, it must be supported by scientific evidence that assure its safety, efficacy, and quality.
In Argentina, herbal medicines are regulated under the category of “medicinal plants” by the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), or the National Administration of Drugs, Food, and Medical Devices. And to be approved as a medicinal plant, a product must be supported by scientific evidence to ensure its safety, efficacy, and quality.
Conclusion
It can be concluded that herbal medicines have a growing market in the ASEAN and LATAM regions, but the herbal ingredients used in the products are subject to varying regulations. The ASEAN region is still in the early stages of regulating herbal medicines, with the Regulatory frameworks varying from one country to another, whereas in the LATAM region, the regulations for herbal medicines are more developed, with a common Regulatory framework for most countries. Manufacturers need to be compliant with the prevalent regulations and maintain consumer trust if they wish to sell their products in these two markets.
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