Update Report on the activity of the HMA Task Force on R esources for MRP and DCP
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Transcript of Update Report on the activity of the HMA Task Force on R esources for MRP and DCP
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Update Report on the activity of the HMA Task Force
on Resources for MRP and DCP
Christer Backman
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Based on:
Meeting of the HMA Task Force on Resources for MRP and DCP
Uppsala, Sweden
23 March, 2011
New chair
Christina Åkerman, Sweden
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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
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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
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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
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(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 andWP on Future of CMDh
Contribution to implementation of HMA Strategy 2011-2015
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(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
Contribution to implementation of HMA Strategy 2011-2015
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(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
Contribution to implementation of HMA Strategy 2011-2015
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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
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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
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Validation issues
• Templates are being used• Still issues both from MSs and MAHs• Need more discussions in CMDh• Eudralink need improvement – TSG - TMC
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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
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Clock stops
• More follow up
• Need better statistics
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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.
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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)
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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
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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
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Transparency of slot opportunities
• Already transparent but…….• Closer monitoring, update of information
• Is there really a problem…….• Cancellation of slots – 30-50 %
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Follow up with industry
• CMDh already do• WP on Future plan to do
Proposal
For HMA TF on resources – use HMA stakeholders meetings!
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Next steps
• Await guidance from HMA strategy lead (Gro)
• Report on progress to HMA in July