Update Report on the activity of the HMA Task Force on R esources for MRP and DCP

1. Update Report on the activity of the HMA Task Force on Resources for MRP and DCP Christer Backman

2. Based on: • Meeting of the HMA Task Force on Resourcesfor MRP and DCP • Uppsala, Sweden • 23 March, 2011 • New chair • Christina Åkerman, Sweden

3. Main items on TF Agenda – 23 March 2011 • Contribution to implementation of HMA Strategy 2011-2015 • Ad hoc group on ASMF – separate presentation by Christa Wirthumer Hoche • Validation issues • National requirements • Clock stops

4. Main items on TF Agenda – 23 March 2011 • Time for issuing MAs • Assessement report feedback forms • More areas for worksharing • Transparency of slot oppurtunities • Follow up with industry

5. Contribution to implementation of HMA Strategy 2011-2015 • (37) Optimum utilization of resources, including financial, 5.64, 5.65 • Report on task force on resources in MRP/DCP • Working Group of Quality Managers

6. Contribution to implementation of HMA Strategy 2011-2015 • (38) Making decentralized processes work better, 5.66, 5.67 • Coordinated Group for MRP and DCP (V+H) • Working Group of Quality Managers • Task Force on Resources in DCP and • WP on Future of CMDh

7. Contribution to implementation of HMA Strategy 2011-2015 • (39) Extending new EU variation regulation provisions to national variations, 5.66 • Coordinated Group for MRP and DCP(V+H) • Working Group of Quality Managers • Task Force on Resources in DCP

8. Contribution to implementation of HMA Strategy 2011-2015 • (40) Supporting new functionality bestowed on CMD-h by strengthened pharmacovigilance legislation, 5.66 • Coordinated Group for MRP and DCP • Task Force on Resources in DCP • Proposal – Best Practice session in HMA Nov 2011 on the need of national resources for the new PhVig tasks

9. Contribution to implementation of HMA Strategy 2011-2015 • (41) Providing more authorized medicines for children and implementation of paediatric regulation provisions, 5.66 • Coordinated Group for MRP and DCP • Task Force on Resources in DCP

10. Contribution to implementation of HMA Strategy 2011-2015 • (42) Promoting work sharing and principle of fair distribution of work across the Network, 5.68 • Coordinated Group for MRP and DCP (V+H) • Task Force on Resources in DCP

11. Validation issues • Templates are being used • Still issues both from MSs and MAHs • Need more discussions in CMDh • Eudralink need improvement – TSG - TMC

12. Electronic validation • still problems with disharmonised technical validation • depending both on different validation tools and different handling by MSs • TIGes has adopted new technical validation criteria for eCTD and NeeS to be used by all NCAs by September 2011 • Training/workshop is planned for all MSs at EMA in time before September • The technical validation process also have to be better defined; proposal that RMS do the technical validation on behalf of all CMS in DCP and MRP • Important that: • HMA endorse the use of the harmonised validation criteria (no other national) • HMA send a representative to the validation workshop ( reimbursed by EMA) • HMA endorse the idea of RMS to do technical validation and in their agencies secure the tools (free of charge) and skills for it

13. Clock stops • More follow up • Need better statistics

14. National phase • EGA results of survey based on 2864 national procedures finalized in 2009 and 2010. • Great variance by country for MA grant times. • According to EGA 12 MS are showing a tendency or slight tendency to decrease average MA grant times between 2009 and 2010. • For other MSs, there was either no trend to decrease or large variability so no overall conclusion could be drawn.

15. National phase • Issue a MA with product information in English (SE model) • legal aspects in MS? • Do we have national requirements after the end of the procedure for issuing a MA ? • updated application form (in national language) • special forms/declarations to be filled in • submission of ‘artwork’ • reimbursement questions (including slot requests)

16. Assessment Report feedback form • Aim: • To reach more consistency in preparing Assessment Reports; • To reduce Parallel Assessment; • To facilitate mutual recognition; • To identify areas for improvement (recommendations, training, …) • Decided to have a report to HMA in July in order to evaluate in November

17. More areas for worksharing? Formal work sharing procedures • PSURs • Paediatrics • Variations • PMFs • Others? Informal work sharing procedures • Sharing of assessment reports for ongoing and approved national (including DCP/MRP) procedures • Ad-hoc work sharing arranged at level of CMD eg shortage of radiopharmaceuticals More brainstorming needed

18. Transparency of slot opportunities • Already transparent but……. • Closer monitoring, update of information • Is there really a problem……. • Cancellation of slots – 30-50 %

19. Follow up with industry • CMDh already do • WP on Future plan to do • Proposal • For HMA TF on resources – use HMA stakeholders meetings!

20. Next steps • Await guidance from HMA strategy lead (Gro) • Report on progress to HMA in July