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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 An agency of the European Union 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 1 Next Steps: • 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 • • 2 Scientific/technical considerations Define sustainability modalities for project and operational phases Regulatory Data Flow 3 G-SRS Business Process & Technical Specifications • Substance registration maintained internally within the EUEMA 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. 4 EU Network-FDA Substance Registration/Data Sharing Concept 5 Establishment of a EU-Network/FDA (IDMP) Joint Scientific/Technical Governance Board(s) for substance registration and maintenance operations 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 6 Thank you 7 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)20 3660 7168 Facsimile +44 (0)20 3660 5555 E-mail [email protected] Follow us on @EMA_News