1. PHC-34 643796 Meeting the global challenge of unique identification of medicinal products SMS, RMS and OMS : Common Terminologies for enabling ISO IDMP Contact: Kevin Horan ( kevin.horan@hpra.ie )kevin.horan@hpra.ie www.open-medicine.eu TOWARDS A TRANS-ATLANTIC SOLUTION TO UNIVOCALLY IDENTIFY MEDICINAL PRODUCTS USA-EU Workshop FDA White Oak Campus, 10903 New Hampshire Av., Silver Spring, MD is a project funded by the in the context of

2. PHC-34 643796 in the context of is a project funded by the S.P.O.R. - How its comes together Product Data Referentials Common terminologies, building blocks for product and substance data set. Product European database of products for human and veterinary medicines. Substance Single source of substance information for the network. Organisation Unique European identifier for organisations e.g. Marketing authorization holders, manufacturers

3. PHC-34 643796 in the context of is a project funded by the Referentials – Scope To provide a single, trusted source of referentials data to be used across the EU Regulatory Network and Pharmaceutical Industry, with consistent and well-understood mechanisms to update and consume referentials lists Human & Veterinary Domains

4. PHC-34 643796 in the context of is a project funded by the Referentials – What Are They ? Pharmaceutical forms Routes of Administration Units of measure ATC codes Examples EDQM EMA ISO WHO MSSO Providers Broker service will be provided by EMA

5. PHC-34 643796 in the context of is a project funded by the Provide a single source for referential data for all stakeholders to use, with each referential list having a clearly defined purpose Referential - Outcomes to be delivered There is no single source of referentials (multiple organisations & systems) and there are multiple referentials for similar purposes Provide a federated operating model in which EMA acts as a data broker, with a standard process for stakeholders to request changes. There are multiple Maintenance Organisations (MOs) managing referentials lists, each with different processes to manage changes. Existing issuesOutcomes to be delivered Allow Industry to consume referential lists via a documented and standardised interface. Lists only available to Industry via files at EMA’s website, no technical interfaces to facilitate incorporation into systems. Provide the capability to efficiently identify and resolve data quality issues in referentials data Costly, manual effort is required to resolve inconsistencies and data quality issues, which are not always identified. Streamlined business processes for the creation, maintenance and sharing of the lists with the EU Network and Industry. Existing methods of managing changes to lists and creating new lists within the EMA are manual, resource intensive and costly The above issues will become unsustainable with the increased workload resulting from the transition to IDMP

6. PHC-34 643796 in the context of is a project funded by the Referentials - Stakeholder impacts New method to request updates to Referential Alignment to EU-wide terminologies List change requests needs to be made via a new user interface, which triggers an evaluation process More comprehensive evaluation may result in longer lead times – provisional terms provided in the meantime Industry need to map their own terminologies to the EU-wide Controlled Vocabularies for use in IDMP submissions Member states Industry NCAs integrating EU terminologies into their own procedures will need to map their existing lists to the EU ones All Controlled Vocabularies (CVs) required for IDMP and other regulatory submissions will be available from a central source Availability of Referentials lists via a new solution A new web based application will replace the current EU Telematics Controlled Terminology ( EUTCT) services such as list search and download System interface will provide access to new Referential services – EUTCT- backward compatible interface provided

7. PHC-34 643796 in the context of is a project funded by the Referentials – Focus 2016  Terminologies currently available via current EUTCT.  National Competent Authorities (NCAs) have started reviewing their use of the current terminologies available.  A number of NCA’s have started to map national terminologies, and have developed processes and software to enable mapping.  New referentials service due July 2016

8. PHC-34 643796 in the context of is a project funded by the Substances – Scope To build a comprehensive list of substances in EU with a harmonised definition, supported by an standardised data exchange model, available in an easily accessible format aimed to power business and regulatory processes in EU and at global level. As adopted by EU ISO IDMP Task Force 12 June 2015 Human & Veterinary Domains

9. PHC-34 643796 in the context of is a project funded by the Substances – What Are They ? Substances active, excipients and adjuvant Multiple sources Plan to use Global Substance Registration System (GsRS) Broker service will be provided by EMA

10. PHC-34 643796 in the context of is a project funded by the Single method to manage substance data to support all procedures Substances - Outcomes to be delivered Competent Authorities hold substance data in different formats, resulting in inconsistent versions Common substance terminology granular enough to identify scientifically relevant aspects of each substance Substance definition is not harmonised globally, leading to different terminologies used to support regulatory activities Existing issues Outcomes to be delivered A dictionary of substances that is compatible based on internationally harmonised definitions available from a single source that can interoperate with other systems used in performance of regulatory activities Different systems in EU leads to duplication of maintenance effort, inefficient data sharing across the regulatory network causing inconsistency in information provided to the stakeholders

11. PHC-34 643796 in the context of is a project funded by the Substances - Stakeholder impacts Industry will need to update their own substance terminologies to the EU- wide submissions Member states Industry NCAs integrating substance terminologies into their own procedures will need to map their existing lists to the EU ones Alignment to EU-wide substance terminologies Substance, Product, Organisation, Referential8 Impact on NCAs will be analysed within the EUNDB and will depend on the strategy for the implementation of the target operating model – these will be communicated at a later date

12. PHC-34 643796 in the context of is a project funded by the Substances – Focus 2016  NCA’s have started reviewing and planning for the mapping.  End of Q4 2016 implementation guide available.  New substance service due Q2 2017.  Implementation Q4 2017

13. PHC-34 643796 in the context of is a project funded by the Organisations – Scope To provide a consolidated source of high-quality and standardised organisation data to be used across the EU Regulatory Network, that can support all regulatory activities Human & Veterinary Domains

14. PHC-34 643796 in the context of is a project funded by the Organisations – what are they? Marketing Authorisation Holders Manufacturing sites Regulatory Authorities Applicants Clinical trial sites Examples

15. PHC-34 643796 in the context of is a project funded by the A single repository within the Agency holds Human and Vet organisation data, cleansed and consolidated with organisation identifiers Organisations - Outcomes to be delivered Organisation data held in several different repositories and is of varied quality, inconsistent and duplicated. A central EU-wide operating model process for the lifecycle management and control of organisation data. Lack of standardisation on organisation data management across EU reduces effectiveness & efficiency in data exchange and sharing. Existing issuesOutcomes to be delivered Single repository acts as a source of truth across regulatory activities, and provides a single identifier for each organisation. NCAs, Industry and EMA required to enter the same organisational data through different processes and systems, duplicating effort A single registration process, across both Human and Vet, that includes verification. Information is not always independently verified when it is entered. Allow for individuals to be associated with organisations, and organisations to be associated with each other. The Agency cannot manage the relationship organisations have with other organisations and associated individuals. Provision of a dictionary with structured and standardised organisation data, which will support ISO IDMP implementation Organisation information is submitted in an unstructured resulting in data inconsistencies and lack of standardisation

16. PHC-34 643796 in the context of is a project funded by the Organisations - Stakeholder impacts Availability of cleansed and consolidated organisation dictionary Alignment with Organisation IDs in the new dictionary New process for registration of Organisations NCAs will be able to make use of a consolidated and cleansed EU-wide d ictionary of organisations Adaption of own systems to connect to EMA system interface. No impact to access web user interface Industry to pre-register organisations with EMA prior to any regulatory data submission EU Organisation IDs will be provided with the dictionary to support NCAs to map it to their own data Member states Industry NCAs can request organisation registration at EMA as part of their national regulatory procedures Industry will use a single and unique Organisation ID in subsequent interactions with regulators EU Organisation IDs will be provided with the dictionary to support Industry to map it to their own data

17. PHC-34 643796 in the context of is a project funded by the Organisations – Focus 2016  Organisational service available in Q3 2016 with different deliverables depending on the type of organisation (i.e. MAH, MAA, Sponsor, Manufacturer, etc).  NCA should start to review current data structures for organisations and consider adding a new field to capture the EU Org ID.  Implementation plan being drafted by EUNDB organisational sub group.

18. PHC-34 643796 in the context of is a project funded by the SPOR in context of other EU roadmaps EU Telematics strategy 2014- 2016 EU Telematics strategy and implementation roadmap 2015- 2017 Veterinary IT and Data Strategy, Roadmap and Management Overview EMA Master Data Management roadmap (SPOR) HMA eSubmission roadmap Provides the SPOR services to be used in eSubmission Describes MDM roadmap for Telematics strategy’s Data Integration programme Provides the SPOR services to be used by Veterinary EU Medicines Agencies Network Strategy to 2020

19. PHC-34 643796 in the context of is a project funded by the 19 Programme timelines The focus for 2016 is on implementation of Referential and Organisations RMS & OMS roadmaps

20. PHC-34 643796 in the context of is a project funded by the 20 Programme timelines Referential and Organisations will lay the data foundations for Products & Substances Implementation