1. 22 February 2019
Trans-Atlantic regulatory cooperation and harmonisation Focus on IDMP: next steps
Towards a trans-atlantic solution to univocally identify medicinal products
USA-EU Workshop
21 June 2016
FDA White Oak Campus
Presented by Paolo Alcini on 20 June 2016
Head of Data Standardisation and Analytics
European Medicines Agency

2. IDMP Task Force Topic Leads
22 February 2019
IDMP Task Force Topic Leads
European Medicines Agency (EMA)
Paolo Alcini
Francisco Penaranda
EUNDB MS representative
Thomas Balzer
US Food and Drug Administration (FDA)
Vada Perkins
Mary Ann Slack

3. Next Steps: Complete ISO IDMP TSs and TR
22 February 2019
Complete ISO IDMP TSs and TR
Create a global HL7 SPL “message” to exchange ISO IDMP compliant medicinal product and structured substance data
Carry a feasibility analysis aimed to establish if G-SRS is suitable to be adopted by EU. If the outcome is positive:
Define a solution in terms of business processes, interface and technical deployments to allow FDA/EU to assign unique IDs, keep EU and US instances in sync, allow exchange of information between US and EU
Define common principle for the assignment of IDs
Define a joint governance structure
Scientific/technical considerations
Define sustainability modalities for project and operational phases
Next Steps:

4. 22 February 2019
Regulatory Data Flow

5. G-SRS Business Process & Technical Specifications
22 February 2019
G-SRS Business Process & Technical Specifications
Substance registration maintained internally within the EU- EMA and FDA firewalls
Two way communication/updates from “internal to internal” and “internal to external” sources (public information) based on internationally accepted “sources of truth” and conformance with confidentiality/trade secret requirements.

6. EU Network-FDA Substance Registration/Data Sharing Concept
22 February 2019
EU Network-FDA Substance Registration/Data Sharing Concept
Establishment of a EU-Network/FDA (IDMP) Joint Scientific/Technical Governance Board(s) for substance registration and maintenance operations

7. G-SRS Business Process & Technical Specifications
22 February 2019
G-SRS Business Process & Technical Specifications
Establishment of a bilateral framework (e.g., MOU, Cooperative Agreement) to support a joint governance process for substance registration and maintenance.
EU Network/FDA will establish agreements with each other for substance registration & maintenance which includes an overarching scientific and technical* governance process.
Registration & maintenance between EU-Network and FDA for substance terms and unique IDs.
Resource for EU-Network/FDA Substance ID that maps to other regional IDs (harmonization).
*Technical refers to G-SRS software and core IDMP compliant system requirements

8. 22 February 2019
Thank you

9. Thank you for your attention
22 February 2019
Thank you for your attention
Further information
Paolo Alcini
Head of Data Standardisation and Analytics
European Medicines Agency
30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom
Telephone +44 (0) Facsimile +44 (0)
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