New GACP Guidelines Bring Stricter Requirements for Medical Cannabis

GMP and GACP – two parts of the same system 

To put it simply: GMP (Good Manufacturing Practice) defines how medicines must be manufactured to ensure the highest levels of quality and safety. GACP (Good Agricultural and Collection Practice), on the other hand, governs the agricultural side – how plant-based raw materials are grown and harvested. These two frameworks are interconnected: only when GACP and GMP work seamlessly together can the pharmaceutical quality of cannabis flowers be guaranteed. 

Change is coming after nearly 20 years 

The European Medicines Agency (EMA) is currently revising the GACP guidelines, which have remained unchanged since 2006. After nearly two decades, an update is long overdue – the market for herbal medicines has changed a lot since then, including medical cannabis. 

A closer alignment with GMP requirements is expected as part of the revision. While quality checks have always been necessary, the previous rules left room for interpretation. The new guideline is likely to spell out these requirements more explicitly, providing greater clarity. Documentation obligations are also expected to become more stringent. In the future, producers will need to demonstrate without gaps every step a plant undergoes from cultivation through to the finished product. Finally, more extensive validations will be required — a point that comes with investments, whether in systems, or digital tools for traceability in systems and tools for quality management. 

“For us in Quality Management, the key point is this: the new GACP guideline does not fundamentally change our day-to-day operations, it simply describes existing requirements in a more precise way. This reduces room for interpretation and creates more clarity. It also makes it easier for us to coordinate with new suppliers to ensure that the highest quality standards are maintained. In the long run, the entire market will benefit from the more efficient availability of new, safe, and high-quality products.” 

— Dr. Richard Böser, Vice President of Quality at Cansativa

More trust through clear standards 

The new requirements are not a revolution — the quality of medical cannabis has always been safeguarded by the GMP process. What the revised GACP guideline does is shift the focus earlier in the chain: it ensures, better than before, that quality is consistently documented and secured right from cultivation. 

For patients, this doesn’t change the end result — they have always been able to rely on safe products. But the added clarity brings greater transparency, reduces room for interpretation, and makes cooperation across the supply chain easier. For the young medical cannabis industry, this is an opportunity to further strengthen efficiency and trust — and to secure its place in the European healthcare system for the long term. 

Anything else?

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We wish you a good read!

Best wishes from both of us,