Contribution of PSCI in Empowering Pharmaceutical Supply Chain
Contribution of a world-class regulatory system to the future of the pharmaceutical industry in...
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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