Slide 1

The contribution of a world-class regulatory environment to the

future of the industry in Ireland

Pat O’MahonyChief Executive, Irish Medicines BoardChairman, European Medicines Agency

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

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 evaluationPharmacovigilanceScientific adviceNetwork of over 4,500 European expertsReferrals and arbitration

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.

Slide 5

47 NCAs ANDHEADS 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

Environmentalanalysis

• Proportionate regulation

• Consistency of

implementation /

harmonisation, e.g.

Clinical trials work

• Veterinary regulation

• Interactions

with industry/

stakeholders

• Website presence

• Resources

• IT

• Training

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.

Slide 7

IMB INTERNATIONAL PROFILEEUROPE

Provides significant resources to the European network

Chair of the Board of the EMAActive participant in many EMA working

groupsParticipant in the Heads of Medicines

Agencies (HMA)(provides secretariat resource to the network)

Active participant in HMA working groups including the CMDh, CMDv, WGEO

Slide 8

IMB INTERNATIONAL PROFILEEUROPE (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

Slide 9

IMB INTERNATIONAL PROFILEOUTSIDE 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

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

Slide 11

INTERNATIONAL REGULATORYCOOPERATION 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

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

Slide 13

The contribution of a world-class regulatory environment to the

future of the industry in Ireland

Thank you!

Pat O’MahonyChief Executive, Irish Medicines BoardChairman, European Medicines Agency