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.
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.
International GDP and GLP standards require careful, controlled protocols.
Once you have registered your flower API and the appropriate regulatory agency has accepted the dossier, distribution or further processing adheres to good distribution practices (GDP), and manufacturing follows pharmaceutical GMP. These guidelines and processes have specific requirements for what you are making. Cannabis is a controlled narcotic and requires additional security and properly registered transportation groups to handle and protect the distribution of a controlled substance. GDP and GMP also regulate the cleanliness and air temperatures in the products’ processing or storage rooms. GMP even regulates the airflow inside processing rooms, equipment specifications, cleaning protocols and a litany of requirements for creating products consistently by following protocols and addressing deviations in a controlled fashion.
Good laboratory practices (GLP) are also a large part of product and medicine registrations. Self-governing labs and reporting your lab results at various steps in your processes is crucial to making consistent medicinal products. From the flower to the extraction to distillation and through to formulation and primary packaging, the lab will collect samples to verify conformity. And above the lab is a quality assurance (QA) team monitoring the results, paperwork, and processes by the production team. In simplified flow, the production teams work to make products and send samples throughout the process to the lab for verification, and the QA team watches that procedures are adhered to, and results are in line. The QA team addresses deviations and regulators’ inquiries, all while working to produce consistent medical products registered with regulators.
The impossibility of pharmaceutical cannabis in North America
To a large extent, the adult-use markets of the U.S. are unregulated due to non-federal recognition; otherwise, their governing body would be the Food and Drug Administration (FDA). However, the general rules are not even novel foods GMP and resemble restaurant rules modified with semi-medical requirements like standard operating procedures (SOPs) and independent lab verifications because these are state-regulated entities.
These regulations differ significantly from the strict pharmaceutical GMP standards and the non-standardized global medicinal manufacturing level. Additionally, the buildings’ physical modifications, air handling units, and regulatory requirement updates would make it impossible for almost every facility in the U.S. or Canada to conform to international medicinal standards.
To clarify, it’s unlikely international markets will ever accept U.S. products due to the product manufacturing requirements Europe has adopted.
European operators are poised to lead the global pharmaceutical cannabis market.
In comparison, Europe has strictly adopted the proper medical and pharmaceutical standards for cannabis product growing, drying, manufacturing and distribution. Furthermore, when Europe transforms to an over-the-counter (OTC) model that resembles the adult-use markets of North America, the standard of medical-grade products will enable mainstream distributors and sales outlets like pharmacies to accept the higher standards of products easily.
The global manufacturing and distribution of cannabis require standards to which only novel foods and pharmaceutical GMP products can conform. Additionally, due to cannabis’ scheduling as a psychotropic narcotic, the global rules governing bodies require the trade of pharmaceutical-grade GMP medicines.
These registered APIs and finished market-authorized drugs have the highest quality standards for consumer sale around the globe and can be sold as pharmaceuticals or OTC products that do not require a regular prescription as most drugs do.
As early markets like the U.S. fix cannabis’ federal legal status, they will have to grapple with regulations that could be minimal and follow novel foods GMP or possibly maximal, unachievable pharmaceutical GMP standards. Either way, producers must meet some criteria for consumers’ safety and the products’ uniformity.
Michael Sassano is a health care executive.
