Substances Co-ordination Status page

Next steps in EMA Substances coordination

Notes: At least two countries have extracts for potential promotion, and the use case isn't clear as to how specific the concept needs to be.  Must the part of the plant be specified (root, seed, flower, bark, etc.)?  It is specified in drug/SPC labels.  However, of the 93 extract substances in the international edition, it's often not specified (neither is it specified in the country's potential promotions).  Must the extraction method (e.g., alcohol, water, CO2) be specified?  What about the form (powder, dry or soft extract, tincture, etc.)?  Consider the substances' use in allergy reporting.

Related to backlog topic: 

• Increase range of has active ingredient to include microorganisms and natural products (Guillermo, CA, AU)

Request for feedback on Patches strength representation (Agreement for "Vaginal delivery system (unit of presentation)")

• Less Granular Clinical Drug
• Elemental Substances (Matt, AUS)
• Substances Co-ordination (MF/2025 Priority topic)
  • Step 1: Substances in multiple extensions Batch promotions complete, SI review and authoring underway
  • Step 2: Substances in one extension
  • Step 3: Ongoing Substance Co-ordination (capturing at regulator level)
• Medication Stopped v Medication Discontinued (Karen, SI)
• Medicinal Product promotion co-ordination (Oslo group discussion as linked to substances work + ES)
• Top level children of 373873005 |Pharmaceutical / biologic product| hierarchy - are members using/how are members using? (AUS) 
• Increase range of has active ingredient to include microorganisms and natural products (Guillermo, CA, AU)
• Link between Substances and the organism they come from (Cat dander protein → Cat organism) see PCP-68
• Units of Measure - proposal for rationalisation of concepts (Emma, UK)
• Rounding rules - update on where SI is at with current guidance (Linda, CA)

• Adding |Dose form after transformation| to the Dose form concept model (Linda, CA)

Done or in progress:

• Hydration Subsumption 'Option 3' proposed by DEUSG for communication/consultation with MAG and EAG
• Group Input on Patch Strength Representation Briefing note now being implemented
• Dose Form Intended Site v Route of Administration (BEL) Pending implementation use-cases associated with intended site
• Drug extension MRCM attributes (CA, AUS) SI facilitating links with CA and AUS for cross-promotion, next steps: other countries to be invited to add to catalogue
• Value range of a |Has container type| attribute (Linda, CA)
• Routes of Administration - Implementation Considerations (Mia, NZ)