Building a link between ectd and xevmpd
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The webinar discusses the integration of the electronic Common Technical Document (eCTD) and the European Medicines Agency's Extended Pharmacovigilance Data Model (XEVMPD) to enhance pharmacovigilance. It emphasizes the importance of improving signal detection and optimizing medicine use to protect public health and reduce adverse effects, potentially saving thousands of lives annually. Key tasks outlined include better data management and transparency, direct consumer reporting, and the establishment of robust regulatory processes involving stakeholders like pharmaceutical companies and healthcare professionals.
Building a link between ectd and xevmpd
- 1. Building a link between eCTD and XEVMPD Samarind Webinar – 21st June 2013 Michiel Stam Qdossier B.V.
- 2. 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 2 Agenda Why new pharmacovigilance regulation? • Improve signal detection by more specifically attribute adverse events to medicines • XEVMPD is just one of the tools for pharmacovigilance Other (Pharmacovigilance) documentation needs to be considered in this context • Overview of all kind of structured information requested in the EU What to learn • Conclusions
- 3. Need to improve public health Medicines save lives and relieve suffering, but…. • Can also cause side effects • 5% of all hospital admissions • Nearly 200,000 deaths per year in the EU Promote and protect public health by • Reducing burden of side effects • Optimizing the use of medicines 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 3
- 4. 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 4 Considering Data collection and management Benefit-Risk assessment Signal detection Safety Issue evaluation Regulatory action Communication Audit
- 5. Impacts Actors • EMA (PRAC) • NCAs • Pharmaceutical companies • Patients and Health Care Professionals Entire product lifecycle Estimated to save between 500 and 5000 lives per year • savings to society of €250- 2,500 million/year 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 5
- 6. How? All MSs introduce direct consumer reporting Establishment of PhVg Risk Assessment Committee (PRAC) Robust EU decision making Engaging patients and health care professionals Science based Risk proportionate Greater proactivity Reduced duplication and greater efficiency Increased transparency and better information 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 6
- 7. Direct consumer reporting 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 7
- 8. Direct consumer reporting 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 8
- 9. Tasks Industry: • Maintain PhVg System Master File • Regulatory documents in eCTD (incl. cover letter, application form) • PSURs evaluate benefit-risk; not only focus on safety • Modular RMP • Summary of PhVg System master file PRAC to provide expert advice on safety and benefit-risk Transparency and communication • Coordination of PhVg inspections • Routine PhVg audits • Better funding for public health protection Better definition of intervening medicinal products • XEVMPD (To be submitted by XEVPRMs) 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 9
- 10. SFDA campaign food additives 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 10
- 11. 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 11 Marketing License through CTD ICSRs by E2B PhVg System Master File by GVP ICSRs Manu- facturing License through GMP WW MA status RMP Interface Patient benefit/risk ratio
- 12. EU Envelope 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 12
- 13. Cover letter Initial MAA + Variations 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 13
- 14. Cover letter Post-authorisation commitments 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 14
- 15. Application form 1 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 15
- 16. Application form – 2, etc 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 16
- 17. RMP Part I “Product overview” Active substance information: • active substance(s); ATC code; name MAH or applicant; date and country of first authorisation; date and country of first launch worldwide; number of medicinal product(s) to which this RMP refers. Administrative information on the RMP: • DLP RMP; date submitted and version No.; list of RMP modules (incl. date and version No.) • for each medicinal product included in the RMP: • authorisation procedure; invented name(s) in EEA; • brief description of the product (incl. chemical class) • indications: • dosage: • pharmaceutical forms and strengths: 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 17
- 18. RMP part II “Safety specification” Module SI Epidemiology of the indication(s) and target population(s) Module SII Non-clinical part of the safety specification Module SIII Clinical trial exposure Module SIV Populations not studied in clinical trials Module SV Post-authorisation experience Module SVI Additional EU requirements for the safety specification Module SVII Identified and potential risks Module SVIII Summary of the safety concerns 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 18
- 19. RMP Interface ToC 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 19
- 20. RMP interface – Administrative 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 20
- 21. RMP interface – Product 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 21
- 22. RMP interface – Indications 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 22
- 23. RMP interface – Risks 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 23
- 24. RMP interface – Interactions 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 24
- 25. RMP interface – Missing information 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 25
- 26. New PSUR - mandated since 10 Jan 2013 Part of a regulatory submission (e)CTD Module 5.3.6 Benefit-risk (not only safety) and cumulative • Based on AEs instead of ADRs • More structured evaluation based on cumulative data • No summary bridging reports or addendum reports • No acceptance of multiple 6 monthly reports Assessment leads to automatic regulatory action • variation, suspension, revocation Submission frequency will be variable (based on risks) EMA list of substances with submission dates • Union Reference Dates and periodicity of submissions (EURD) list 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 26
- 27. (EURD) European Union reference date 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 27
- 28. PhVg System Master File (on file only, replacing DDPS in dossiers) General details • EV code or local code (XEVMPD) • Name of MAH, the MAH of the QPPV (if different), relevant QPPV 3rd party (if applicable) • Name of concerned MAH(s) • List of PhVg system master files with different PhVg system • Date of preparation/last update MAH organization Sources of safety data Computerized systems and databases QPPV particulars PhVg processes PhVg system performance Quality system Related documents • List of products covered by this PhVg MF, incl. • MA #, Rapporteur or RMS, market presence • Other (non-EU) territories • Specific safety monitoring requirements • Roles and Responsibilities if 3rd parties are involved 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 28 Upon request, a Change control logbook, versions and archiving details may be requested
- 29. Summary of PSMF (mandated >July 2015) Replacing the DDPS in dossiers Proof that Company has a QPPV at its disposal Statement of pharmacovigilance competence Member states in which QPPV resides and carries out his tasks QPPV contact details PSMF location (Code as in XEVMPD) 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 29
- 30. XEVMPD database filled by industry, owned by EMA (mandated >2 July 2012) Organization (MAH and QPPV details) ATC code (as in SmPC) Pharmaceutical Form (EMA vocabulary) Route of administration (EMA vocabulary) Substance (EMA vocabulary) • Structured substance information not mandated yet • Would have much more data Product details • Next slide Attachment • corresponding SmPC for verification QPPV details 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 30
- 31. Example of Product details 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 31
- 32. Conclusion What to learn from all these formats and forms requesting structured information? 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 32
- 33. Conclusion CMC its relation to XEVMPD Regulatory information should be reused at various eCTD documents, RMP interface and XEVMPD/IDMP How? • Develop internal standards • Leverage (do not copy!) from existing standards • Inherit values across disciplines, documents and tools • Define mapping and automate correlation to other standards • Envelope, cover letter, application form, XEVMPD, IDMP, Module 3, etc. Manage properly the regional aliases and translations, to support beyond the EU too 21-JUN-2013 Building a link between eCTD and XEVMPD - Qdossier 33