2026-01-15: DEUSG Virtual

 Substance Linkage and Editorial Guidelines

Monica presented an update on linking substances to their biological origins, highlighting the completion of a briefing note approved by Kelly and Jim. She discussed the need to determine whether the briefing note should be shared with the wider community or included as an agenda item for the member forum. Guillermo raised concerns about changes to editorial guidelines regarding the use of extracts and the impact on existing proxy concepts in the substance hierarchy. Matt acknowledged these concerns and noted that the current proposal focuses on linkage rather than remodeling, but agreed that further discussion is needed on the broader implications for existing proxies and editorial guidelines.

EMA Content Import Process Design

Alejandro reported on Krista's work to design a process for importing EMA content periodically, focusing on new human medicines under evaluation. The content team is developing criteria to filter and exclude certain types of substances, aiming for monthly updates. Shane and Alejandro discussed the importance of capturing newer substances at the international level to prevent parallel creations by member countries. Guillermo raised a question about potential changes to the acceptance criteria for concepts already approved by EMA or other regulatory bodies. Monica suggested a wider discussion on this topic, involving Jim. Alejandro shared information about the 2026 EDQM work, highlighting three new dosage forms and seeking feedback on their value and potential inclusion in SNOMED.

Pharmaceutical Classification and Data Standards

The group discussed several topics related to pharmaceutical product classification and data standards. Stuart confirmed that none of the three specified dose forms are currently used in the UK, and Alejandro suggested opening a forum thread for countries to review and provide input on future dose forms. Linda presented four ongoing topics: products with no active ingredients, non-terminating strength rounding policy, substance linked to organisms, and dose form after transformation. The group agreed to share the SQL algorithm for the rounding policy in a GitHub repository, and Linda summarized four options for handling products with no active ingredients. Shane requested feedback from the group on these options, particularly regarding Yong's review of the first option.

Modeling Inactive Substances in Drugs

The team discussed how to model inactive substances in a drug product, focusing on alignment with the IDMP standard. They concluded that inactive substances should be represented through specialized attributes in the model, allowing for the strength of inactive substances to be modeled even when active ingredients are unknown. Guillermo explained that for products without known active ingredients, a flag or product characteristic could be used, though this might not qualify as a clinical drug. The discussion highlighted the need for flexibility in representing products that don't meet traditional clinical drug requirements, while maintaining compatibility with regulatory requirements.

Modeling Inactive Ingredients in Drugs

The group discussed challenges with modeling inactive ingredients in clinical drugs, particularly regarding how to handle packages that contain both active and inactive ingredients. Linda proposed a solution involving counting the base of active ingredients, which could be useful for ECL and comparative mathematical operations. The team agreed to schedule further discussion of this topic at the next meeting in February, along with other items including dose form transformation and non-terminating rounding policy. Guillermo noted that Canada's proposal for a new attribute to model administrable dose forms was supported by IDMP and FHIR implementation, though this was considered a future step rather than an immediate priority.

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