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EU and USA Harmonisation of Content and Message Exchange for IDMP Implementation

EU and USA Harmonisation of Content and Message Exchange for IDMP Implementation. Vada A. Perkins. HL7 Structured Product Labeling (SPL) specification as enabler of EU/US exchange of medicinal product information. HL7 SPL(R7) Publication.

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EU and USA Harmonisation of Content and Message Exchange for IDMP Implementation

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  1. EU and USAHarmonisation of Content and Message Exchange for IDMP Implementation Vada A. Perkins

  2. HL7 Structured Product Labeling (SPL) specification as enabler of EU/US exchange of medicinal product information

  3. HL7 SPL(R7) Publication • HL7 SPL(R7) Publication: To be submitted by this Friday (ballot approved) • SPL Release 7 as the data exchange format to support ISO IDMP Technical Specifications. The ISO IDMP Technical Specifications describes the data exchange for the five (5) ISO International Standards • Incorporates European Union (EU)/European Medicines Agency (EMA) requirements for EU implementation of the five IDMP standards utilizing HL7 SPL to support their legislative requirements for product registration and pharmacovigilance. • 92 data elements • SmPC requirements

  4. ISO IDMP Normative Standard e-Message for Data Exchange:Common Product Model (CPM) • The Health Level Seven (HL7) Common Product Model (CPM) provides: • Overarching information model • Reusable Common Message Element Types (CMETs) • Consistent data types and conformance rules • Vocabulary domains • Schemas for data exchange

  5. Style Sheet View/Source Code (XML)

  6. FDA Relevant “SPOR” • Registrant • Contact • Address • Telephone number • Email address • Establishment/Facility • Name (business) • Contact • Address • Telephone number • Email address • ID (DUNS, FDA ID, EMA/EU ID) • Business Operations • GPS coordinates • Importer • Contact • Address • Telephone number • Email address • ID (DUNS, FDA ID, EMA/EU ID) • GPS coordinates • In Country Contact (e.g., US Agent) • Name (business) • Contact • Address • Telephone number • Email address • (DUNS, FDA ID, EMA/EU, ID)

  7. EMA/EU Data Elements • Around 20 data elements were removed/ streamlined/ re-modelled → 74 Data elements in PMS Iteration 1 • If it is agreed to include 5 data elements to cover Shortage and Marketing information → Total 79 Data elements in PMS Iteration 1

  8. Language/Code <!-- SPL header --><document> <id root="1d90e8f0-2065-4f8c-a85a-9a186904fc14"/> <code code="34391-3" displayName="human prescription drug label"codeSystem="2.16.840.1.113883.6.1"/> <languageCode code="en_US" codeSystem="2.16.840.1.113883.6.121"> and the section: <section> <id root="be362bdc-9458-4625-ba03-d663b4534962"/> <code code="34089-3" displayName="description section"codeSystem="2.16.840.1.113883.6.1"/> <text>Description</text> <text>Goodmedicine is a white to off-white powder ...</text> <languageCode code="en_US" codeSystem="2.16.840.1.113883.6.121">

  9. Link to the Original Source of Translation <!-- SPL header --><document> <id root="e56fef83-7eff-41d1-a122-fa5cac99317c"/> <code code="34391-3" displayName="human prescription drug label"codeSystem="2.16.840.1.113883.6.1"/> <languageCode code="fr_FR" codeSystem="2.16.840.1.113883.6.121"> <setId root="20d9b74e-e3d8-4511-9df9-cec2087372fc"/> <versionNumber value="1"/> <relatedDocumenttypeCode="DRIV"> <relatedDocument> <id root="1d90e8f0-2065-4f8c-a85a-9a186904fc14"/> </relatedDocument> </relatedDocument>

  10. Package and Submission of Multiple Translations • When required, each SPL file (having one language) should be packaged in its own folder. The name of the folder may contain the language code

  11. Implementing IDMP: The Pivotal Role of the PhPID (Pharmaceutical Product Identification)

  12. Paracetamol (aka acetaminophen)

  13. Paracetamol/Acetaminophen • PhPID_SUB_L1 paracetamol • PhPID_SUB_L2 paracetamol, 1000 mg • PhPID_ SUB _L3 paracetamol, tablet • PhPID_ SUB _L4 paracetamol, 1000 mg, tablet • PhPID_SUB_L1 paracetamolPhPID_SUB_L2 paracetamol, 500 mg • PhPID_ SUB _L3 paracetamol, capsule • PhPID_ SUB _L4 paracetamol, 500 mg, capsule • PhPID_SUB_L1 paracetamolPhPID_SUB_L2 paracetamol, 750 mg • PhPID_ SUB _L3 paracetamol, tablet-film coated • PhPID_ SUB _L4 paracetamol, 750 mg, tablet-film coated

  14. FDA algorithm (beta) for PhPID Generation Substance 2 Substance n Dose form Substance ID Strength Substance ID Strength Alphabetic order of UNII code ・・・ Input NCI thesaurus code UNII code Normalized unit UNII code Normalized unit MD5 digestion MD5 is a widely used algorithm for hash function. Substance 1 PhPID code (example) 128 bit (16 byte) number which, in hexadecimal presentation, is 32 digits long formatted in groups of 8-4-4-4-12  digits separated by hyphens -Globally Unique Identifier (GUID) Output

  15. ISO “SPOR”: Global Harmoni(sz)ation • Medicinal Product ID (MPID) • Regional Identification • Pharmaceutical Product ID (PhPID) • IDMP (algorithm) • Based on core elements for identification of medicinal products • Demands harmonization of terminologies/IDs for globally unique identification (internal and external to EU). • Substances • Global Substance Registration System (G-SRS) • EMA/EU-FDA Bilateral (governance) • Units of measurement • Unified Code for Units of Measure (UCUM) • Dosage forms-mapping exercise (ongoing) • European Directorate for the Quality of Medicines (EDQM)

  16. Policy Pathways to Implementing IDMP in the US (FDA) OpenMedicine 20 June2016 Mary Ann Slack (CDER) Vada A. Perkins (CBER)

  17. Overall high level plan for SPOR (updated) Transition Phase Preparation Phase Maintenance Phase Product & Substance Submission Product & Substance Pre-Submission • R • Build technical services • Controlled vocabularies for IDMP • Terminology alignment • Registration of new terms • Expand and manage content O • Build technical services • Initial organisation dictionary • P • Finalisation of ISO documentation (standards review and Technical Specifications) • Terminology alignment • Finalisation of EU Implementation Guides (EU IGs) • Preparation for electronic submission • Terminology alignment (continuation) • Implementation of initial electronic submission • Expand and manage content (based on Iterations) • S July 2016 Q3/Q4 2016 Q1/Q2 2017 Q1/Q2 2018 Q3/Q4 2018 Kick off Product & Substance Iteration 1 Enforcement of Product & Substance Iteration 1 Legal deadline Publication of EU IGs

  18. Why Implement IDMP? • FDA needs to be able to organize and “connect” relevant data to support both pre-market and post-market activities • FDA and other regulatory authorities need to share information to aid in safety and compliance activitiesExample: identifying global drug safety issues • Product information must be consistently described to be understandable across regional boundaries • A common exchange structure enables sharing critical data Medicinal product identification and SPL enable this organizing and sharing this data

  19. How Might FDA Implement IDMP? • Through regulation • Through guidance • With the enactment of FDASIA in 2012, through “binding” guidance

  20. What is a Statute? A statute is a law passed by the U.S. Congress Examples: • Food, Drug and Cosmetic Act, 1938 (established what is now the U.S. FDA) • Food and Drug Administration Science and Innovation Act (FDASIA), 2012

  21. What is a Regulation? A rule issued by FDA consistent with U.S. law, published in the U.S. Federal Register and contained in the Code of Federal Regulations (CFR) Functions of regulations:

  22. What is U.S. FDA Guidance? • FDA’s current thinking on how to comply with a particular statutory, regulatory requirement or issue • A guidance, unlike a statute or regulation, does not establish “legally enforceable rights or responsibilities” and do not bind the public or FDA • Generally, guidance is prepared by FDA staff

  23. Food and Drug Administration Safety and Innovation Act, July 2012 • Congress authorized FDA to implement statutory electronic submission requirements by specifying the format for such submissions in guidance • Section 745A(a) – Drugs and Biologics • Applies toallsubmissions for INDs, NDAs, ANDAs and BLAs, including supplements, DMFs, and drug/device combination products • Noncommercial IND exemption • Unlike our usual ‘Guidance for Industry’ documents, this guidance is binding.

  24. FDA Safety and Innovation Act (FDASIA) • Section 1136 of FDASIA (Jul 9, 2012) amended the FD&C Act by adding new section 745A, which addresses electronic submissions. • Starting 24 months after final guidance for a specific submission type, Sponsors must use the standards defined in the data standards catalog (for submissions for NDAs, ANDAs, and BLAs). • Guidance document for Submissions Under Section 745A(a): • Effective date: December 2016 (CDISC: SDTM) • Effective date: May 2017 (e-CTD)

  25. How may required eSubmissions be Implemented? Individual Guidances NDAs, ANDAs, BLAs, INDs 24 Months after Final Guidance • Timetable • Content • Format

  26. FDASIA Guidance Implementation Highlights

  27. In Summary • FDA is working to implement IDMP internally • Pathways exist for recommending or requiring standardized electronic submission of IDMP data • If FDA determines that the best path is to require standardized electronic submissions, that requirement would be a minimum of 24 months after final guidance is issued.

  28. US FDA IDMP Roadmap Paper to Electronic Submission (HL7 CPM/SPL, eCTD) Transition phase to ISO IDMP Publication 2004 2005 2006 2007 2008 2009 2014 2010 2011 2012 2013 2015 2016/2017 ** US FDA FR Notice/ Guidance (Draft) Content of Labeling SPL Indexing GDUFA Self-ID of Facilities, Sites, Organization LDD, WDD/3PL, 3911 Establishment Registration/Drug Product Listing • HL7 SPL(R6) &(R7)/ CPM (R2) &(R3) SPL (R4) SPL(R5) SPL (R1) SPL (R3) HL7 V3 (Normative to ISO IDMP) SPL (R2) ISO Publication of ISO IDMP Standards ISO IDMP New Work Item (NWI) Proposals IDMP TS/Standards Revision (5 year cycle) **US FDA SPL Implementation Guide (technical specification) updated with corresponding Guidance for Industry (incorporated by reference) http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm2005542.htm Reference: Vada Perkins ISO /FDA IDMP Topic Lead/Expert

  29. FDA Implemented (IDMP/SPL)

  30. Global Identification of Medicinal Products (IDMP) Lifecycle SPOR

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