1. CMD(h) Report Progress report Truus Janse-de Hoog HMA meeting Budapest 28-29 April 2011

2. Contents Statistics 2010/2011 Training new Members GCP IWG-CMDh mandate Future of CMDh New Pharmacovigilance legislation

3. CMDh contribution to implementation on HMA Strategy 2011-2015 Discussed in meeting of the HMA TF on resources, 2 March in Uppsala CMDh will work together with TF and contribute to discussion on how Decentralised procedures can work better. In addition: CMDh will contribute to following topics - CMDh new tasks in relation with Pharmacovigilance legislation - Paediatric Worksharing - ad hoc group on ASMF- presented by Christa Wirthumer Concrete target suggested for implementation: reduction in number of referrals

4. Percentage of procedures referred in MRP since 2006

5. Percentage of procedures referred in DCP since 2006

6. Number of procedures Q1 2011/2010 N.A. finalised N.A. ongoing Referrals CMD(h) Agree- ment in CMD(h) Referrals CHMP MRP 52/ 57 MRP 39’/ 90 MRP 1/ 5 MRP Ref 2010: 2 Ref 2011: 0 Withdrawn:1 MRP 2010: 1/1 2011: 0/0 DCP 300/336 Withdrawn 26/ 9 DCP 1880/ 1737 DCP 4/ 1 DCP Ref 2010: 0 Ref 2011: 0 Withdrawn: 2 DCP 2010:0/1 2011: 0/0

7. Article 45 – waves 1- 11 Updated on 11 April 2011

8. Article 46* Worksharing per Number of Studies until end of March 2011 * Art. 46 Rapporteurs appointed by the CMDh Secretariat according to the BPG Art. 46 Updated on 11 April 2011

9. Training new members In April for first time training new members organised with help of experienced members and CMD secretariat 13 participants: BU,BE,CY,DE,PT,RO,SL Topics: Task and mandate CMDh, organisation of meetings, Paediatric Worksharing, PSUR Worksharing, organisation of work at national agencies: acting as CMS and RMS

10. CMDh-GCP IWG Representatives of CMDh and GCP meet regularly to discuss GCP related issues in relation with MRP/DCP applications Annual programme for Risk based approach for routine Inspections of the CRO’s most often used for BE trials Guidance paper for cooperation and communication on outcome of inspections Proposal for Mandate

11. Mandate GCP-CMDh subgroup (1) The group will coordinate and monitor an annual risk based programme of routine inspections of the CRO’s most often used in conduct of BE trials The group will communicate the outcome of GCP inspections on a routine basis to CMDh. In case of a negative outcome of Inspection a summary report will be presented to CMDh

12. Mandate GCP-CMDh subgroup (2) The group will be involved in the development of Guidance papers, procedures and templates to facilitate exchange of information To provide a forum for discussion for GCP inspectors and assessors of scientific issues of common interest (eg triggers for inspection) To give feedback to the GCP IWG and CMDh Question to HMA: Can they endorse this mandate?

13. CMDh-GCP IWG Other topics for discussion: Should CRO’s that have never been inspected always been inspected before granting marketing authorisation? No resources available at EU level for these inspections, some MSs regard this a potentially risk to public health Training needed to enlarge group of inspectors for BE trials Eudract shows that only limited number of MSs have performed Inspections on BE trials

14. WP on Future of CMDh WP on Future CMDh will continue to meet and discuss Implementation plans, eg from TF of self- medication New topics Update on Rules of procedure CMDh Implementation of new Pharmacovigilance requirements

15. TF on implementation of PhVWP legislation Mandate Responsible to WP on the future of CMDh to assist CMDh in the practical implementation of the new pharmacovigilance legislation To identify tasks and measures required by CMDh in readiness for the new legislation To propose a workplan to ensure that all necessary work is undertaken Ensure good liaison with the EMA/MS project teams, Project Coordination group and ERMS