Update Report on the activity of the HMA Task Force

on Resources for MRP and DCP

Christer Backman

Based on:

Meeting of the HMA Task Force on Resources for MRP and DCP

Uppsala, Sweden

23 March, 2011

New chair

Christina Åkerman, Sweden

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

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

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 

(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

(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

(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

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

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

Validation issues

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

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

Clock stops

• More follow up

• Need better statistics

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.

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)

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

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

Transparency of slot opportunities

• Already transparent but…….• Closer monitoring, update of information

• Is there really a problem…….• Cancellation of slots – 30-50 %

Follow up with industry

• CMDh already do• WP on Future plan to do

Proposal

For HMA TF on resources – use HMA stakeholders meetings!

Next steps

• Await guidance from HMA strategy lead (Gro)

• Report on progress to HMA in July