As global cannabis trade accelerates, quality assurance (QA) and GMP/GACP-aligned systems aren’t optional, they’re the backbone of export success.
Canada Leads Today But What Happens When the U.S. Joins?
Canada remains the dominant exporter into key medical markets like the UK, Israel, Portugal and Germany. In Q2-2025, Germany imported
43,257 kg of medical cannabis, nearly
half (20,107 kg) coming from Canada - up from
16,057 kg in Q1. Portugal was second at
13,465 kg.
What could unlock U.S. exports.
The U.S. is moving toward a federal shift (e.g., rescheduling to
Schedule III has been formally proposed and is under rulemaking), which, while not full legalization, signals a break from the Schedule I status quo and opens the door to a more normalized federal framework over time.
To be clear, there
are medical-only, CBD-only markets that are very much accessible by US operators, assuming their finished products meets the importing jurisdictions’ THC thresholds, which in some cases – like Japan for instance – is as low as 0.001% THC, significantly lower than the US federal hemp threshold of 0.03% THC. That said, eventual federal reform could unlock significantly larger export opportunities for US operators.
What Canadian and American Operators Can do to Prepare to Export
1. Design for treaty-grade exports.
- Build a documentation package that satisfies Single Convention shipment-by-shipment controls: import permit match, export authorization, batch reconciliation, destruction logs for variances. UNODC
2. Pursue EU-GMP alignment ahead of the turn.
- Gap-assess state-level GMP vs EU-GMP (Annex 11, data integrity) and FDA expectations for records. Validate electronic systems, signatures, and audit trails now—don’t wait for the rush. U.S. Food and Drug Administration
3. Pilot with import-friendly markets.
- Map requirements for Germany/UK/Israel and assemble a “golden dossier” (MBR/EBR, CoAs, stability, change control history, GDP logistics). Use Canada’s current flow into Germany as your template for volume planning and documentation structure.
4. Build a digital export ‘compliance bridge’
- Centralize: SOPs, deviations/CAPAs, supplier qualifications, transport validation, and permit chains in a
21 CFR Part 11 / Annex 11–validated eQMS so each export file can be generated and audited instantly. Adhering to ALCOA++ principles (strict data integrity framework) is essential to demonstrate full proof of compliance and trust.
Spotlight: Digital Compliance Bridge to Japan
C15 has implemented, with a Japanese partner a secure digital compliance bridge to Japan’s medical market. By integrating batch records, permits, and certificates of analysis into a closed, validated environment, the platform has given the Japanese Ministry of Health a single source of truth to review all inbound product data to facilitate the certification. The entire process is the process aligned with GMP, 21 CFR Part 11 and EU Annex 11 expectations and the technology enforces ALCOA++ data integrity principles so the Ministry of Health know that has been no manipulation to batch records or test results. This system enabled real-time regulatory submission, replacing error-prone, slow manual workflows and notifications.
Importers in target export jurisdictions already have some elements of this compliance bridge, however, often it is paper based evidence demanded. Time consuming procurement forms and re-testing [products] due to lack of trust.
Conclusion: Trust and Growth Demand Digital Quality
Global cannabis export/import is built on trust: regulators, patients, and partners need assurance that products are safe, consistent, and compliant. A digital QMS grounded in GMP and QA best practices delivers:
- Regulatory alignment across markets (EU, UK, Israel, Asia)
- Operational excellence through traceable, auditable data
- Competitive advantage through export-readiness and speed
Quality isn’t just regulatory hygiene, it’s a strategic advantage. With a solid digital QMS, companies don’t just meet markets they build trust and unlock global opportunities.
