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.
Read more at Valor International