The National Health Surveillance Agency (ANVISA in Portuguese) has presented an update regarding the measures taken by the Agency to comply with the ruling of the Superior Court of Justice (STJ in Portuguese) concerning the cultivation of cannabis solely for medicinal and pharmaceutical purposes.

The ongoing work aims to adhere to the aforementioned STJ ruling, which acknowledged the right to import hemp seeds, as well as to plant, cultivate, and market industrial hemp exclusively for medicinal and pharmaceutical uses.

The report highlighted several issues that need to be addressed in the regulatory debate, which are already being tackled by ANVISA’s technical teams. These include:

• Compliance with the judicial decision.
• The definition of scientific research involving cannabis.
• The potential impacts of future regulations on existing judicial decisions and the judicialization process.
• The necessary timelines for regulatory compliance and the internal implementation of the proposed regulation.
• The effects that establishing a maximum percentage of THC (tetrahydrocannabinol) could have on cannabis-based medications and products already registered with the Agency that exceed this percentage.

According to the speaker, the discussion regarding the THC percentage limit is one of the central points that must be analyzed in the regulatory process to ensure it does not become an obstacle to the research and development of new medications.