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 RegulationCommunicationNetwork 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