2026-04-30: DEUSG Virtual

Summary

Forum Feedback on Implementation Guide

The meeting involved brief discussions about recording tools and updates on forum feedback. It was mentioned that feedback is open for discussion in a forum post and it is encouraged for everyone to contribute.

Substance Classification Discussion

The team discussed generating summaries and questions for project documents using AI, with work on business case documents and briefing notes for coverage and clarification needs. They explored different approaches to defining cannabis substances, including a phased approach where DNA/RNA links might be straightforward while plant products linked to organisms may require more investigation. The team identified key challenges around substance classification, including the difficulty of defining all chemical compounds and the distinction between substance groups and physical objects in the SEP model.

Natural Products Model Discussion

The team discussed a model for natural products and substance-organism linkages, with Canada mentioning existing research backed by existing papers. Concerns were expressed about the top-down analysis approach used in the original drug model design and emphasized the importance of using real data from databases, particularly those in Canada that use UNII codes. The group agreed to analyze Canada’s document as a starting point and gather real-world data to guide the scope of their work, rather than defining abstractions first.

Medicinal Cannabis Product Modeling Approaches

The team discussed modeling approaches for medicinal cannabis products and dose forms. Australia shared insights from an 18-month project in Australia involving industry consultation on medicinal cannabis products, which could inform the current discussion. The group then reviewed options for modeling dose forms, particularly focusing on a reconstituted Diamox example where a 500mg powder is transformed into a 5mg per milliliter injection solution. Two modeling approaches were proposed: using new attributes for administrative dose forms or enhancing FSN terminology to clearly distinguish reconstituted products from manufactured products. The team agreed that FSN descriptions need to be explicit about both manufactured presentation strengths and concentration strengths of transformed products.

Pharmaceutical Product Modeling Concepts

The group discussed modeling concepts for pharmaceutical products, particularly focusing on how to represent manufactured dose forms and their administrable counterparts. Australia suggested using separate concepts for the powder and reconstituted solution forms rather than trying to model both states in a single concept. An alternative proposed using dual axioms to represent both the powder presentation strength and the concentration strength of the reconstituted solution. The discussion highlighted the need to balance international terminology standards with local regulatory requirements, with participants noting that different countries may have different approaches to strength representation and dilution requirements. The group agreed to continue research and further discussion in future meetings to better understand how to accommodate these realities in their modeling approach.