1. An agency of the European Union EU ISO IDMP Roadmap to enable eprescription cross-borders Towards a trans-atlantic solution to univocally identify medicinal products USA-EU Workshop 21 June 2016 FDA White Oak Campus Presented by Kevin Horan on 21 June 2016 Health Products Regulatory Authority, Ireland

2. EU Network Data Board (EUNDB) Advisory body Acts as the reference point for matters escalated to EMA and National Competent Authorities (NCAs) Comprising members representing Member States, EMA, EC and other key parties Business and IT representatives who understand data needs, technological constraints Reflects programme agreed by European Telematics Management Board (EUTMB) and Heads of Medicines Agencies (HMA) to manage policies, principles that will ensure access to accurate, quality and risk-free data and information Vision: work with the regulatory network to establish data standards and supporting technologies, necessary to support sharing and analysis of data/information Data/information an important asset for the Network EUNDB will agree and act on criteria for escalation to EUTMB 1

3. ISO IDMP Task Force (ISO IDMP TF) Expert working group/advisory group Participants from EMA, members from EU Regulatory Network (including EUNDB), experts nominated by Industry Associations, Software Vendors & interested parties Business and IT representatives with understanding of ISO IDMP standards, regulatory procedures, data policies Vision: Develop the common EU strategy for the implementation of ISO IDMP standards Through ongoing dialogue between the main EU stakeholders who plan to develop and implement the ISO IDMP standards Recommendations made by the TF will be adopted by the Data Integration (DI) Steering Committee in accordance with DI programme and Telematics governance Presentation title (to edit, click Insert > Header & Footer)2

4. ISO IDMP Task Force Members Presentation title (to edit, click Insert > Header & Footer)3 European Federation of Pharmaceutical Industries and Associations (EFPIA) Vaccines Europe (VE) European Biopharmaceutical Enterprises (EBE) European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) EuropaBio Medicines for Europe (formerly EGA) Medicines for Europe (formerly EGA) Eye Care Industries European Economic Interest Grouping (ECI – EEIG) Association of the European Self-Medication Industry (AESGP) EU Network Data Board (EUNDB) 14 members Regulatory agencies Interested Parties Terminology organisation Software vendors Service providers Developers Interested Parties Terminology organisation Software vendors Service providers Developers

5. How ISO IDMP will be implemented? Implementation of IDMP through SPOR (Substances, Products, Referentials and Organisations) methodology (these are four distinct projects) In 2016, priority for the Network is to deliver the first two SPOR projects: Referentials Management Services (RMS) Organisation Management Services (OMS) RMS and OMS provide the data foundation and technical services that will enable implementation of Substance Management Services (SMS) and Product Management Services (PMS) Major programmes (such as Pharmacovigilance, eSubmissions, Clinical Trials, Veterinary) depend on SPOR data SPOR applies to both domains: Human and Veterinary Medicines 4

6. 5 SPOR Re-use of SPOR data for other applications Industry data preparation Data captured and submitted only once Marketing Authorisation Applications, Variations, etc.. Database at EMA Re-use of data for other purposes eg. E- prescription, eHealth, falsified medicines etc Network can use SPOR data for other processes SPOR – The vision

7. Overall benefits Data entered once and can be reused many times, which can lead to operational savings and efficiencies A single source of truth (database) held centrally for Substances, Products, Organisations and Referentials (SPOR) data => faster & better decisions therefore more effective and efficient regulatory actions => impact on public health (e.g. products recalls, safety information) Supporting regulatory needs for both Human and Veterinary Product data will be reviewed, assessed and approved during the Regulatory Activity => Increase in quality of data and simplification of the process Facilitate the identification and exchange of product and substance information in EU and globally 6

8. Made up of… How does ISO IDMP relate to SPOR? 7 Packaging type Pharmaceutical dosage form Route of administration Units of presentation A packaged product Authorised by a Regulatory Authority, e.g. “EMA/EU NCA” for the EU and “FDA” for U.S. Manufactured and/or owned by Version of the regulatory document For use against therapeutic indication Sold under the trade name X Box containing a bottle of 50 tablets Oral tablet consisting of Paracetamol 500 mg, per tablet Paracetamol, Chemical Substance, EU Pharmacopeia grade Manufactured by MPID PhPID SID RfID OrgLocID RfID OrgLocID MAH Medicine Made up of… ISO 11615 Packaged medicinal product ISO 11615 Authorised medicinal product P PPPP ISO 11616 Pharmaceutical product ISO 11615 Packaged medicinal product Medicine PCID P O S R ISO 11238 Substances O ISO 11240 Units of measurement ISO 11239 R SPOR uses unique identifiers to label components of structured data Made up of… …Described using approved and standardised terms OrgLocID O

9. Thank You Presentation title (to edit, click Insert > Header & Footer)8