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Cornelia Ibrahim Chair ESS

Update on PSUR- Synchronisation and Work Share Project. Cornelia Ibrahim Chair ESS. PSUR Work Share Project. PSUR Synchronisation and Work Share Initiative objective:

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Cornelia Ibrahim Chair ESS

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  1. Update on PSUR- Synchronisation and Work Share Project Cornelia IbrahimChair ESS

  2. PSUR Work Share Project PSUR Synchronisation and Work Share Initiative • objective: improvement and harmonisation of risk management for veterinary drugs in the EU and reduction of redundant work for agencies and industry simplification of procedures whilst keeping high safety standards • since 2004 for human medicines • since 2008 for veterinary medicines: pilot phase 2008 - 2009 consolidation phase since 2010 ongoing

  3. PSUR Work Share Project – experience from Pilot Phase Experiences from Pilot Phase -> new conditions since 2010 • all Member States participate • as many MAH as possible participate • DLP-Lists: - published DLPs are not to be changed - add new DLPs only with nomination as originator - splitted DLPs for different application forms or species for same substance - not longer than 2 months apart • PSUR- submission: - originator sends his PSUR for substance with CSDS to all agencies (same document for all) - generics send their PSURs with CSDS only to the agencies,where a marketing authorisation exists - possibility for electronic submission via EudraLink is expanded within EU

  4. PSUR Work Share Project Experiences from Pilot Phase -> new conditions since 2010 Work Sharefor PSUR Assessment Reports: - PSUR Assessment Reports are product related and based on CSDS - PSUR Assessment Reports are produced in work share: „P-RMS“ and commenting „P-CMS“ - PSUR Assessment Reports are based on „Risk based Approach“ -> 3 risk levels -> decides on format of report - each Member State should act as „P-RMS“ at least once a year • coordination: PSSG (PSUR Synchronisation Subgroup) - industry and agencies Regulator‘s Group – all agencies of Member States

  5. PSUR Work Share Project - CSDS Core Safety Data Sheet (CSDS) What is it? • extract of the most relevant safety informationen from the SPCs of the products in the PSUR in English(submitted with PSUR electronically as word – document ) What is it for? • important tool for agencies for evaluation • replaces SPCs in different languages • enables comparison of PSUR-evaluation with relevant information for safety in SPCs for other products with same substance submitted in parallel to NCAs

  6. PSUR Work Share Project - Core Safety Data Sheet (CSDS) Why is it important? • without CSDS a Work Share (WS) between EU-agencies is not possible • PSUR-assessment can induce changes to CSDS • after assessment in WS the CSDS reflects in a product related way the most important safety information as agreed by all MS (inofficiel working document ) CSDS is not a tool for EU wide harmonisation of SPCs

  7. PSUR Work Share Project - Experiences What advantages can be observed? • usefull! reduces work in the long term • since 2008 BVL received Work Share PSURs for 320 veterinary products for 75 products BVL produced a PAR as P-RMS for 160 products BVL received a PAR from other MS • electronic submission helps for assessment

  8. PSUR Work Share Project - Experiences advantages from NCAs point of view: • substance related synchronisation • quality of PSUR assessment reports and harmonisation of EU risk management is improved for MAHs: • 1 PSUR for different agencies simultaneously • PSUR submission in 3 year cycle • automatic prolongation of submission schedule for a PSUR with participation in Work Share is inclusive • PSUR not in different languages – all in English!

  9. PSUR Work Share Project - Experiences What can still be improved? • reduction of double work not yet fully achieved – more administrative efforts for establishing new additional procedures/ still different submission schedules ( national, MRP, DCP, CAP ) • fair distribution of work between NCAsobjective: each agency should act at least 1 x/year as „P-RMS“ –2010 not yet achieved • acceptance of synchronized DLPs by all Member States (HMA-decision 2009) someagencies request based on national law in spite of WS-PSUR separate national PSURs in addition • participation of all MS and all MAHs needed!

  10. PSUR Work Share Project - Experiences What can still be improved? • attention at setting DLPs • keep to assessment time schedule for P-RMS • better use of „Risk based Approach“ • electronic submission not yet possible in all MS

  11. PSUR Work Share Project - Experiences What can still be improved? • quality of presentation of PSURs and Line Listing shows big differences • CSDS is sometimes missing • originator does not submit same documentation in all MS • PSUR is not identified, as being submitted in Work Share

  12. PSUR Work Share Project - Future perspective objectives not yet fully met more effort needed from industry and NCAs more pragmatic, less administrative approach needed point of view of NCAs: - synchronization of DLPs and assessment reports - work share between „P-RMS“ and commenting „P-CMS“ - use of „Risk based Approach“ - CSDS contribute considerably to work reduction !

  13. Thank you for your attention

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