The European Pharmacopoeia’s cannabis flower monograph, the official standard for classifying cannabis flower in Europe, is set for a significant revision following a proposal by Broughton Group, a UK-based analytical testing and regulatory consultancy. The change, reviewed in June 2025 by the European Directorate for the Quality of Medicines (EDQM), aligns classification criteria with the chemical profiles of freshly cultivated THC-dominant cannabis, improving compliance and patient access to medicinal cannabis.
The existing monograph has posed challenges for THC-dominant cannabis flower, which typically contains over 90 per cent tetrahydrocannabinolic acid (THCA) and less than 1% THC in fresh samples. The high-performance thin-layer chromatography (HP-TLC) test requires a visible THC band of specific intensity, often resulting in compliant products being rejected. This occurs even when high-performance liquid chromatography (HPLC) confirms their THC-dominant profile, leading to unnecessary delays in patient access.
“Before the adoption of standardised testing frameworks, product classification often relied on producer-supplied information or varied internal testing,” said Beccy Bell, Associate Director of Laboratory Services at Broughton. “This created inconsistencies in how products were assessed. The introduction of HPLC assay data provides a clearer scientific basis for justification, supporting more consistent classification decisions and giving regulators, healthcare professionals and patients greater confidence in product quality and use.”
Broughton identified the problem through routine client testing, noting that multiple GMP-controlled fresh flower samples failed HP-TLC visual criteria despite HPLC verification. Their submission to the EDQM included comparative analytical data, methodological rationale, and real-world examples. They proposed changing the monograph’s wording from “faint to equivalent” to “very faint to equivalent (may be absent),” a revision that reflects the naturally low THC levels in fresh flower where THCA dominates.
The Ph. Eur. expert group reviewed Broughton’s evidence in June 2025 and agreed to recommend the revision for public consultation in Pharmeuropa 37.4 later this year. If adopted, the change could streamline compliance, reduce unnecessary rejections, and strengthen trust in cannabis-based medicines.
The update addresses a critical gap in regulatory standards by ensuring that valid THC-dominant samples are not excluded. This is particularly important for freshly cultivated flower entering the supply chain, where THCA has not yet degraded into THC. It could also set a precedent for future pharmacopoeial revisions, improving confidence among healthcare professionals prescribing cannabis-based treatments.
With over 15 years of experience in analytical science, Broughton has become a leader in cannabis method development in Europe. Their proactive engagement with the EDQM succeeded where previous industry efforts had stalled, marking a rare achievement for a commercial laboratory. The firm continues to collaborate with regulators to support further validation of testing standards.
The proposed revision will open for industry feedback in Pharmeuropa 37.4, with the EDQM encouraging additional sample submissions to reinforce Broughton’s findings. This process highlights the value of scientific dialogue in shaping regulatory frameworks that are both robust and practical.
Accurate classification is essential for quality control, regulatory compliance, and patient safety. By aligning testing methods with the chemical realities of cannabis flower, the revision will support faster access to consistent medicinal cannabis products while reducing the burden on producers and laboratories. Through Broughton’s efforts, the medicinal cannabis sector is moving toward greater reliability and trust, benefiting regulators, healthcare providers, and patients alike.
