The United States and Canada started a movement that began as medical cannabis and quickly exploded into adult-use cannabis markets. "However, the North American operators failed to properly regulate the processes from growing to manufacturing to compete in a global pharmaceutical-level market. Europe has taken the lead as the heavy-weight producer of truly medical-grade pharmaceutical cannabis flowers and products. Notably, many operators in the U.S. and Canada claim to produce medical-grade products, but the structural reality is impossible," says Michael Sassano.
API registration in North America vs. the EU
You must respect requirements when considering registering a medical-grade active pharmaceutical ingredient (API).
Consider cannabis flower cultivation: Although many states and Canada have regulations on how you can grow and what you can use to grow, the pharmaceutical API market is much stricter and requires certification of how you grow and dry. You must grow in line with strict good agricultural and collection processes (GACP) and dry conforming to pharmaceutical good manufacturing processes (GMP) requirements.
Companies that follow European Union-GMP pharmaceutical standards are the gold standard for global medicinal products. The process is regulated, and the reporting and conditions are essential. For example, each new cannabis flower genetic must undergo stability testing to register the API’s shelf life.
Read more at kevinmd.com