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© CBG-MEB 2ICDRA 17 September 2008, Bern
Regulatory systems in the changing environment
Dutch Point of View
Aginus A.W. KalisExecutive Director
© CBG-MEB 3ICDRA 17 September 2008, Bern
Drug Regulation in Europe
27 countries(recently 12 new member states)
European CommissionEuropean CouncilEuropean Parliament
© CBG-MEB 4ICDRA 17 September 2008, Bern
EU drug regulation drivers
• EU regulatory system is based on bringing together scientific evidence and national expertise.
• European Medicines Agency in London• EMeA: important hub, coordinator, and engine.
© CBG-MEB 5ICDRA 17 September 2008, Bern
• Work sharing and creating efficiency.• Networking between EU member states /
national competent autorities• Checks and balances based on diversity and
willingness to learn from each other.• System of national (co)rapporteurs as skeleton
of success and sustainability.
© CBG-MEB 8ICDRA 17 September 2008, Bern
Principles-based vs. Rule-based regulation
… Football, like most American sports, is heavily rule-bound.
…Soccer is a more principles-based game. There are fewer rules, and the referee is given far more authority than officials in most American sports to interpret them and to shape game play and outcomes…
A bad or biased ref can ruin a soccer match in the way that no bad ref can ruin a football match, the lesson being that regulator independence is key in a principles system... Pogatetz is booked after a furious rant at referee
Vink who awards Croatia a penalty in the 4 minute. Economist. Metaphor of the day, April 21, 2008
© CBG-MEB 9ICDRA 17 September 2008, Bern
MEB: division of workload
MEB
Generics
(80% of applies)
Innovation
(20% of applies)
EuropePriorities?
© CBG-MEB 11ICDRA 17 September 2008, Bern
Advanced therapy products
Gene therapy productsGene therapy products
Somatic cell therapy productsSomatic cell therapy products
Tissue engineeredTissue engineeredproductsproducts
Combined ATPCombined ATP
Source: EMeA
© CBG-MEB 12ICDRA 17 September 2008, Bern
Implantable materialsStent coatings
– Nanoporous alumina and hydroxyapatite coatings increase biocompatibility andthus efficient stenting – development phase
• e.g. AlCove Surface GmbH, Germany• Debiotech SA, Switzerland
– Similar coatings carrying drugs for drug-eluting stents – development phase• MIV Therapeutics Inc, Canada
© CBG-MEB 13ICDRA 17 September 2008, Bern
Converging Technologies:Artificial Limbs
RheokneeR: joint filled with fluid with nanoparticles, with a ‘memory’
© CBG-MEB 14ICDRA 17 September 2008, Bern
Converging Technologies:Retinal prosthesis
Second SightR: array of electrodes, attached to the retina and used in conjunction with an external camera and video processing system.
© CBG-MEB 15ICDRA 17 September 2008, Bern
Converging Technologies: Treatment of cancer
• Targeting• Imaging• Therapy• Monitoring
in one molecule
© CBG-MEB 16ICDRA 17 September 2008, Bern
Converging Technologies:Deep Brain Stimulation
Parkinson’s DiseaseSyndrome of Gilles de la Tourette
© CBG-MEB 18ICDRA 17 September 2008, Bern
Globalisation
Different situations in Europe, Asia, America, Africa
–Quality standards (GCP, GMP)–Ethical aspects
Meetings contribute to awareness and mutual understanding
© CBG-MEB 19ICDRA 17 September 2008, Bern
Global discussion and quest for answers
Goal:Development of global standards and practices