Brazilian pharmaceutical first to receive green light for cannabis extract research; competitors focus on isolated CBD
GreenCare, a Brazilian pharmaceutical company specializing in medicinal cannabis, has been authorized by the Brazilian Health Regulatory Agency (ANVISA) to start clinical research for the production of cannabis extract-based medications. It is the first company in the country to receive the green light for this type of product. According to GreenCare, the investment in research and development amounts to R$25 million.
A regulation establishes that only cannabis-based medications may be marketed in the country. A five-year deadline has been set, expiring in 2024 and expected to be extended, allowing pharmaceutical companies to begin clinical studies and seek the necessary approvals.
GreenCare received ANVISA’s green light for research involving cannabis extract, which contains all cannabinoids, while Prati-Donaduzzi obtained agency approval for studies involving isolated CBD—one of the substances from the cannabis plant. Currently, nearly 60% of marketed products are CBD-based, but those containing the plant extract are experiencing the most significant growth.
There is pressure from the domestic industry for regulation and organization of the transition period to authorize cannabis-based products as medications. A significant portion of products enter the country as imports and do not require ANVISA approval, unlike products developed by Brazilian pharmaceutical companies.
In September last year, Sindusfarma, the pharmaceutical industry association, requested ANVISA to revoke Resolution RDC 660 allowing patients to import cannabis for medicinal purposes.
Sindusfarma argues that with the advancement of the national cannabis market for medicinal purposes, with 37 products approved by ANVISA and available for sale in Brazil, importing is not necessary. The organization contends that items produced by the local industry undergo rigorous ANVISA scrutiny while the quality of imported products is uncertain as they lack registration as medication in their countries of origin, and many lack approval as supplements or food as well.
The volume of imports is not growing at the same pace as in previous years. In the first half of 2024, there were 75,800 import requests, a 14.6% increase over the same period in 2023. Between 2019 and 2023, the demand for imports doubled each year.
In pharmacies, from January to September this year, 423,700 units of cannabis-based products were sold, marking a 75.8% increase compared to the same period in 2023. These sales represent R$163.6 million, an increase of about 35% in the same period, according to the Brazilian Cannabinoid Industry Association (BRCann). The organization added that pharmacy-sold products have seen a 35% price reduction over the past two years.
This article was translated from Valor Econômico using an artificial intelligence tool under the supervision of the Valor International editorial team to ensure accuracy, clarity, and adherence to our editorial standards. Read our Editorial Principles.
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