Delivered by Pat O'Mahony, Chief Executive, Irish Medicines Board at the IPHA Annual Meeting 2010.

1. Slide 1
The contribution of a world-class
regulatory environment to the
future of the industry in Ireland
Pat O’Mahony
Chief Executive, Irish Medicines Board
Chairman, European Medicines Agency

2. Slide 2
REGULATORY ENVIRONMENT
IMB operates within the European Medicines
Regulatory System and Network
European Medicines Agency (EMA)
47 National Competent Authorities (NCAs)
And then as part of the Global Network

3. Slide 3
EUROPEAN MEDICINES AGENCY (EMA)
Decentralised body of the European Union
Its main responsibility is the protection and
promotion of public and animal health,
through the evaluation and supervision of
medicines for human and veterinary use
Scientific evaluation
Pharmacovigilance
Scientific advice
Network of over 4,500 European experts
Referrals and arbitration

4. Slide 4
THE EMA ROAD MAP TO 2015
 Is a continuation of the Road Map to 2010 project, building on
current achievements, but also taking due account of the
Agency’s business drivers.
 Provides the Agency’s vision on how it should further develop
itself as a public health Agency.
 Encompasses the Agency’s longer term strategy for both human
and veterinary medicines.
 Recognises the important contribution by the NCAs through the
provision of high-quality scientific resources for the evaluation
and supervision of medicinal products.
 Will be complemented with a document “From Vision to Reality”
and a multi-annual work programme.

5. Slide 5
47 NCAs AND
HEADS OF MEDICINES AGENCIES (HMA)
HMA Strategic Plan 2011-2015
Public and
Animal Health
Regulation Communication Network
• Promoting &
protecting public health
• Pharmacovigilance
• Quality and inspections
Additional areas of
competence, including devices
• Availability of medicines
Environmental
analysis
• Proportionate regulation
• Consistency of
implementation /
harmonisation, e.g.
Clinical trials work
• Veterinary regulation
• Interactions
with industry/
stakeholders
• Website presence
• Resources
• IT
• Training

6. Slide 6
HEADS OF MEDICINES AGENCIES (HMA)
Making a difference over the next 5 years:
key themes to emerge.
- Safeguarding public and animal health.
- Supporting innovation.
- Further improve the operational efficiency
of medicines authorisation by MRP/DCP.

7. Slide 7
IMB INTERNATIONAL PROFILE
EUROPE
Provides significant resources to the European
network
Chair of the Board of the EMA
Active participant in many EMA working groups
Participant in the Heads of Medicines Agencies
(HMA)
(provides secretariat resource to the network)
Active participant in HMA working groups
including the CMDh, CMDv, WGEO

8. Slide 8
IMB INTERNATIONAL PROFILE
EUROPE (contd.)
 Joint Chair of the steering group on the European
Benchmarking of Medicines Agencies (BEMA)
 Member of the European Pharmacopoeia
Commission (Chair 2004-2007)
 Active participant in the Council of Europe Group of
Specialists on Pharmaceutical Counterfeit Products
(PC-ISP). Provided significant proposals in respect of
the convention on counterfeit medical products.
 Active participant in the Official Medicines Control
Laboratories (OMCL) network

9. Slide 9
IMB INTERNATIONAL PROFILE
OUTSIDE EUROPE
Exchange Agreements signed with a number of
international agencies
Participant in International Conference on
Harmonisation (ICH)
Participation in shared inspection plans co-
ordinated through the EMA
Participation in and host (2007) to the
International Summit of Heads of Medicines
Agencies

10. Slide 10
INTERNATIONAL SUMMIT
Some topics
 Cooperation on inspections with EMA, FDA, TGA
and some EU MS
 Global manufacturing
 Clinical trials in developing countries
 Co-operation against counterfeits
 Engagement on HTA
 Regulatory Science
 Herbal medicines

11. Slide 11
INTERNATIONAL REGULATORY
COOPERATION STRATEGY
Specifically IMB will endeavour:
 To support initiatives that enhance public health protection in
the products regulated
 To support the international business based in Ireland and
provide quality assurance externally in relation to all product
leaving Ireland
 To be an active participant in the European regulatory
network and be in a position to influence European policy.
 To support and participate in the development and delivery
of international policy. Areas of particular focus at present
include:
- Anti-counterfeiting
- Common standards for inspection
- Maximising use of available resources, particularly for
inspection
- International network of shared information
particularly in safety data

12. Slide 12
THE IMB – WORLD CLASS?
 Management
 Strategic planning
 Vision and values
 Restructuring – Process based and linked to
technologies
 Funding and funding model
 Staffing – Development and knowledge network
 Outreach – including HTA
 Timelines
 Clinical trials
 Benchmarking – BEMA
(Organisation, Assessment, Vigilance, Inspections)
Fees 2011
- 20% reduction to type II variations
- 10% reduction to type IB variations
- 10% reduction to annual maintenance fees
- 50% reduction to enforcement fees
- 50% reduction to Article 61(3) fees

13. Slide 13
The contribution of a world-class
regulatory environment to the
future of the industry in Ireland
Thank you!
Pat O’Mahony
Chief Executive, Irish Medicines Board
Chairman, European Medicines Agency