EU IG EU Implementation Guide SPOR Taskforce meeting 16 th October - PowerPoint PPT Presentation

EU IG – EU Implementation Guide SPOR Taskforce meeting 16 th October 2019 Presented by Carlos Aicardo Munoz PMS Business Lead An agency of the European Union

Agenda N Item 1. Context 2. EU IG comments 3. EU IG topics addressed by PMS SG 4. Next Steps – EU IG v2 1

1. Context 2

EU Implementation Guide – Timelines SPOR TF led On Jan 2019 the consultation on draft v1 EU IG consultation was launched EMA TC/Webinar Deadline for Industry/NCAs 2019 Publication Jan Feb Mar Apr May Jun Jul Aug Sept Oct Deadline for Deadline for Consolidated Draft PMS EU IG comments with & triaged comments (Human) P SG Technical impact P SG P SG P SG P SG P SG P SG TF meeti 23 P SG P SG 18 15 02 13 30 13 24 08 07 03 16 18 24 11 Introduction Presentation of Initial feedback on consultations results resolution of in SPOR TF comments 3

EU IG Structure Chapters 1, 2, 6 and 7 for consultation Chapters 3-5 and 8 to be created, consulted and released in future versions (its content may be reviewed) Introduction • Chapter 1 – Pre-registration requirements • Chapter 2 – Initial submission • Chapter 3 – Maintenance (out of scope of this version) • Chapter 4 – Data quality assurance (out of scope of this version) • Chapter 5 – Data access/export (deprioritised/possibly to be removed) • Chapter 6 – Technical specs on structure and Format • Chapter 7 – migration guide • Chapter 8 – examples (out of scope of this version) • 4

Draft EU IG – v1 Chapter 1: Pre-registration Introduction Chapter 2: Initial Submission requirements Description: Introduction and • Description: Guidance on how to get document overview • Description: Guidance on which medicinal product • access to SPOR and what to do prior Target audience: all information (field and business rules) shall be submitted • to submission • No pages: 1/2 in the new format Target audience: all • Note : introduction refers to the • • Target audience: Business (operations) and Technical current legal basis of the submission No pages: 1/2 profiles • and scope of the medicinal product Note : Discussions are still ongoing on No pages: 120 • • which should be expanded based on User Roles and registration Note : this is described as process agnostic since the • the outcome of discussions and requirements which will be included in TOM is not finalised. Business process and requirements agreement with Regulatory Network the next version of the document. will be included in a later version of the IG. For information For information For consultation Chapter 7: PMS Migration Guide Chapter 6: API Technical Specifications Description: migration rules between • xEVMPD and PMS including backwards Description: Technical • compatibility rules. specifications for the API, contains Target audience : Art.57 description of principles, security, • stakeholders/ Business / IT/ technical resources, calls, end-points. Target audience: IT/ technical profiles • profiles No pages: 45 • No pages: 80 Note : n/a • • For information Separate consultation work stream 5

2. EU IG comments 6

EU Implementation Guide 23th April 15 th of February 1535 comments received 599 comments + received 435 duplicate comments NCAs Industry NCAs Industry Norway, Sweden, Estonia, Spain, EuropaBIO Denmark EuropaBIO Austria, Germany Bfarm, France Human ANSM and France Vet EFPIA EFPIA-IRIISS ANMV IRIISS ECI-EEIG AESGP ECI-EEIG Medicines for Europe AESGP Vaccines Europe Medicines for Europe Animal Health Europe Vaccines Europe EUCOPE 7

EU Implementation Guide – Overview Total comments per Chapter Chapter 2 Medicinal Product domain comments Total: 2134 1.1. Medicinal product identifier (MPID) 40 1.2. Domain 9 1.3. Type 19 1.4. Combined pharmaceutical dose form 35 It does not include 1.5. Legal status of supply 9 435 duplicate comments 1.6. Additional monitoring indicator 9 1.7. Orphan Designation Status 14 Chapter 2 comments 1.8. Paediatric use indicator 13 1.9. Full Indication text 27 1.10. EURD ID 15 1.11. Product Classification 70 1. Medicinal product 850 1.12. Marketin Status 92 2. Marketing authorisation information 196 1.13. Medicinal Product Name 176 3. Therapeuthic (product) indication 56 1.14. Master File 19 4. Pharmaceutical product 58 1.15 Contact (QPPV) 25 5. Ingredient 206 1.16. Pharmacovigilance enquiry information 16 6. Packaged Medicinal Product 340 1.17. Attached document 103 General comments/ Other 75 1.18. Product cross-reference 49 Preamble 62 1.19. Manufacturing Business Operation 110 0 200 400 600 800 1000 8

EU Implementation Guide – Timelines and Resolution SPOR TF led Continued collaboration with different consultation stakeholders to resolve controversial topics EMA TC/Webinar Deadline for Industry/NCAs 2019 Publication Jan Feb Mar Apr May Jun Jul Aug Sept Oct Deadline for Deadline for Consolidated Draft PMS EU IG TF comments with & triaged comments (Human) meeting P SG Technical impact P SG P SG P SG P SG P SG P SG 23 P SG P SG 16 18 15 02 13 30 13 24 08 07 03 18 24 11 Introduction Presentation of Initial feedback on EU IG Focus Group consultations results resolution of in SPOR TF comments Regular Consultations on comment resolution at P subgroup meetings PMS SG EU IG Focus Group (temporary) 9

EU Implementation Guide – Collaboration EU IG Focus Group (temporary) P Sub Group Continued collaboration with different stakeholders controversial/complex topics Examples used Interpretation on ISO Extracts of guidance 10

3. EU IG topics addressed by PMS SG 11

Medicinal product Combined Medicinal Legal Status of pharmaceutical Product Name Supply when form - Jurisdiction defined at package level Full indication text in ATC code in Marketing plain text / other lists status at Multilanguage other than package level countries WHO 12

Medicinal product Product Cross Manufacturer Business Expansion of Reference for Operation at level of Biological/Vacci Transfers / Manufacturer and not ne indicator Renewals operation Legal Basis for Product Cross Manufacturer Business products approved Reference for Operation type before current Parallel imported absence reason regulatory products framework 13

Marketing authorisation Procedure type Difference between Procedure type controlled Application type and start and end vocabulary Procedure type in date ISO Application Marketing Authorisation date authorisation Status application 14

Pharmaceutical Clinical particulars product Additional values related Link Pharmaceutical product to intended effect and medical device Packaged Medicinal Product Translations for Shelf-Life/Storage Package Description conditions link to on multi-language package item countries Need of manufacturers Data needed on devices at package level 15

EU IG Open Issues Identify an strategy for product legacy data How to tackle information of old products that are not covered as current terms in RMS (e.g. previous legal basis) Consider the impact of TOM in the guidance Identifiers: PMS stable identifier, PCIDs, MPIDs and PhPID 16

4. Next Steps – EU IG v2 17

Development of the EU IG throughout the P&SM phases Iteration 1 We are here Phase 1 Phase 3 Phase 2 Phase 4 Phase 5 Phase 6 Phase 7 Human only EU IG v.1 EU IG v.4 EU IG v.5 EU IG version EU IG v.2 EU IG v.3 Any final refinement control Process Including Any impact from vet xEVPRM agnostic or extension of TOM decommissioning information on implementation / impact Implementation Operating from the TOM Model Publication of EU IG v1 expected in EU IG consultation Jan - April 2019 October - November 2019 EU IG v.1 published Oct– Nov 2019 Guideline considering EU IG consultation all comments received Timing/duration tbc in 2020 Open topics to be considered EU IG v.2 published Tbc in 2020 in future EU IG releases Veterinary – To be confirmed EU IG version EU IG Vet v.1 EU IG Vet v.2 Veterinary (adaptation & control TOM extension if needed) 18 Draft TOM?

Next steps - Road to EU IG v2 Chapters 1, 2, 6 and 7 for consultation Chapters 3-5 and 8 to be created, consulted and released in future versions (its content may be reviewed) Introduction • Chapter 1 – Pre-registration requirements • Chapter 2 – Initial submission • Chapter 3 – Maintenance (out of scope of this version) • Chapter 4 – Data quality assurance (out of scope of this version) • Chapter 5 – Data access/export (deprioritised/possibly to be removed) • Chapter 6 – Technical specs on structure and Format • Chapter 7 – migration guide • Chapter 8 – examples (out of scope of this version) • 19

Next Steps – Road to EU IG v2 Decision on TOM i needed TOM Whenever there is a • Expand EU • Draft v2 EU decision: 3 months IG with IG for • Amend EU additional to adjust the consultation IG with chapters guideline process information Chapters Consultation If no decision, IDMP OM submission of Involvement of PMS SG product data after regulatory 2019 - 2020 20 procedure