1. Overview of the EU regulatory system and governance
PANDRH Conference – 5 September 2013 Ottawa
Presented by: Alexios Skarlatos
European Medicines Agency – Head of Product Information Quality

2. CONTENTS Approval of medicines in the EU
EU assessment collaboration: Organisational aspects
EU assessment collaboration: Enablers and facilitators 2

3. 1. Approval of medicines in EU

4. Marketing Authorisation (MA)
A medicinal product may only be placed on the market in the EU, when a marketing authorisation has been issued
by the competent authority of an EU Member State or
by the European Commission (via EMA)
Structure of MA Application 4

5. EU cooperation in MA assessment: evolution
1970s-80s: First EU initiatives to encourage communication, cooperation and recognition of assessments between Member States
‘Multi-State’ and ‘Concertation Procedures’ Final national Member State decision
1990s: Creation of the European Medicines Agency (1995)
Introduction of the ‘Centralised Procedure’ (1995) and the ‘Mutual Recognition Procedure (1993; mandatory from 1998)
2000s: Revision of Pharma legislation (required after 6y experience) Adapt and prepare for enlargement of EU Introduction of the ‘Decentralised Procedure’ 5 5

6. Drivers of Harmonisation
The global pharmaceutical market -> effective operation of the internal market
Pharmaceutical industry -> facilitate the free movement of medicines
Scientific culture
Patient involvement
Need for worksharing -> avoid unnecessary duplication of efforts
Fear of the unknown - insecurity

7. Obstacles to harmonisation
Giving up sovereignty
Need for compromising
Heterogeneous cultures
Language issue
Uneven levels of capacity/experience
Uneven share of the workload

8. Current Marketing Authorisation procedures in EU
Approval in 1 MS => National Authorisation procedure
Approval in n or all MSs => EU Authorisation procedure
3 EU procedures: Centralised Procedure (CP)  1 single EU MA Mutual Recognition Procedure (MRP) Decentralised Procedure (DCP)  n national MAs
Route? Choice? Depending on type of product and authorisation history in EU Regulatory & marketing strategy Company preferences etc …

9. Eligibility to the Centralised Procedure “Mandatory Scope”
Biotech products - New Active Substances for Cancer, Diabetes, AIDS, Neurodegenerative, viral and auto-immune diseases - Orphan medicinal products - Cell & gene therapy + tissue engineered products
“Optional Scope”
- Other new active substances - Innovative uses of ‘old’ substances - Interest of patients at EU level - Generics of centrally-authorised products

10. 2. EU assessment collaboration: Organisational aspects10

11. National Competent Authorities (NCAs)
EMA and the European Regulatory Network
EMEA
Secretariat
Working Parties
Committees
National Competent Authorities (NCAs)

12. Resources in the Centralised Procedure
National Competent Authorities (NCAs) in 28 EU Member States. EMA not intended to replace NCAs, but to be a trusted partner in the EU Regulatory Network
> 3500 scientific experts nominated by Member States Available for scientific work & assessments for EMA
Scientific committee (CHMP) delivers a final opinion
Multidisciplinary assessment teams in MS to perform assessment (as Rapporteur/Co-Rapporteur) or participate as ‘peer reviewer’
Services are provided to EMA on the basis of a cooperation agreement
All agencies linked by secure IT network (EudraNet)
Fees received by EMA  payment of (Co-)Rapporteur

13. CHMP: Committee for Medicinal Products for Human Use
Chair and Vice Chair +
1 member + 1 alternate/MS
max. 5 co-opted members
accompanied by experts
            
            
            
            
            
            
            
            
            
            
Ian Hudson Vice-Chair CHMP
Tomas Salmonson
Chair CHMP
+ 5 co-opted members 13

14. Support for MRP & DCP: Coordination group
Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh)
Initially, voluntary ‘Mutual Recognition Facilitation Group’
Recognised and legal mandate in EU legislation revision
Representatives of all Member States
Agree on common rules procedural / regulatory matters Guidance to applicants
Discuss and solve scientific issues during MRP/DCP
EMA: secretariat, organisation of monthly meetings at EMA

15. 3. EU assessment collaboration: enablers & facilitators15

16. Harmonised legal requirements (high level) for Marketing Authorisation Application
Harmonisation of technical standards and requirements ICH guidelines, incl. eCTD CHMP scientific guidelines - applicable to CP, MRP, DCP
Provision of regulatory guidance Agreement on common approaches & procedures Commission guidelines CHMP and EMA guidance documents, Q&As, SOPs  Advice to applicants  Consistent approach/interpretation between Member States 16

17. Common templates for assessment reports
Working together in expert Working Parties or ad-hoc groups e.g. Quality Working Party GCP inspectors working group
Training of assessors
Common templates for assessment reports
‘Twinning’ projects, e.g. for new EU Member States
Years of confidence building, working together, worksharing
Oversight and management by ‘Heads of Medicines Agencies’ (HMA) Group
Secure communication tools and databases 17

18. Member State cooperation in MRP and DCP
«Coordination Group for Mutual Recognition and Decentralised Procedures» CMDh, since Nov 2005 Replaces the informal MRFG group Coordination and facilitation of the operation of MRP and DCP Discussions on procedural/regulatory issues, guidance docs + scientific discussions on applications where MSs disagree Ensure consistency of standards and good decision-making Avoid referrals to EMA 18

19. Disagreements in MRP and DCP: only on the basis of ‘potential serious risk to public health’  Commission Guideline: definition and examples  CMDh: ensure common understanding and application
Harmonisation of national SmPCs of originators, in order to facilitate approval of generics accross EU
Commission guidelines on MRP and DCP procedures + CMDh publication of ‘Best Practice Guides’ Procedural guidance documents Q&A
Worksharing and working group initiatives, coordinated by CMDh e.g. on PSURs and Active Substance Master Files 19 19

20. Head of Product Information Quality + 44 207 418 8682
Thank you
Alexios M. Skarlatos
Head of Product Information Quality 20