Cannabis is considered both a pharmaceutical and agricultural product. To ensure its quality, safety, and efficacy, these industries have high levels of regulation. There are two key regulatory frameworks that govern these industries: Good Manufacturing Practices (GMP) amd Gppd Agricultural Practices (GACP).
GACP regulations control the activities carried out in a plant from its cultivation or growth until its harvest, to ensure that the plants maintain their efficacy, safety, and high standards. They cover aspects such as soil quality, cultivation practices, pest control, harvesting methods, and post-harvest processing. Compliance with GACP ensures sustainable production and traceability of medical plants and helps maintain the quality and safety of herbal medicines available in the EU market.
GMP regulations describe the principles and procedures for manufacturing and controlling the quality of pharmaceutical products, ensuring consistency and compliance with the required quality standards. They cover asoects such as facility design, equipment validation, documentation, and product testing. Compliance with GMP is mandatory for pharmaceutical companies operating within the EU and for those exporting products to EU markets.
The European Medicines Agency (EMA) and the European Commission continuously update and enforce these regulations through inspections, audits, and guidelines to keep up with the envolving scientific knowledge and technological advancements.