ICDRA 17 September 2008, Bern © CBG-MEB 1 17 September 2008, Bern © CBG-MEB 12 Implantable...


Regulatory systems in the changing environment

Dutch Point of View

Aginus A.W. KalisExecutive Director


Drug Regulation in Europe

27 countries(recently 12 new member states)

European CommissionEuropean CouncilEuropean Parliament


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.

http://www.emea.europa.eu/home.htm


• 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.


Distribution of (co)rapporteurallocations in EU


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


MEB: division of workload

MEB

Generics

(80% of applies)

Innovation

(20% of applies)

EuropePriorities?


Innovation more interesting than

generics…??


Advanced therapy products

Gene therapy productsGene therapy products

Somatic cell therapy productsSomatic cell therapy products

Tissue engineeredTissue engineeredproductsproducts

Combined ATPCombined ATP

Source: EMeA

http://images.google.co.uk/imgres?imgurl=http://www.kcl.ac.uk/depsta/biomedical/randall/images/fluo-mul.jpg&imgrefurl=http://www.kcl.ac.uk/depsta/biomedical/randall/methods/im-fluo.html&h=600&w=763&sz=77&hl=en&start=82&tbnid=h9N0A2ViQ7rUCM:&tbnh=112&tbnw=142&prev=/images%3Fq%3Dcells%2Bfluo%26start%3D72%26gbv%3D2%26ndsp%3D18%26svnum%3D10%26hl%3Den%26sa%3DN


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


Converging Technologies:Artificial Limbs

RheokneeR: joint filled with fluid with nanoparticles, with a ‘memory’


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.


Converging Technologies: Treatment of cancer

• Targeting• Imaging• Therapy• Monitoring

in one molecule


Converging Technologies:Deep Brain Stimulation

Parkinson’s DiseaseSyndrome of Gilles de la Tourette


International influences


Globalisation

Different situations in Europe, Asia, America, Africa

–Quality standards (GCP, GMP)–Ethical aspects

Meetings contribute to awareness and mutual understanding


Global discussion and quest for answers

Goal:Development of global standards and practices


C O L L E G E

T E R B E O O R D E L I N G V A N

G E N E E S M I D D E L E N

C B GM E B

M E D I C I N E S

E V A L U A T I O N

B O A R D

ICDRA 17 September 2008, Bern © CBG-MEB 1 17 September 2008, Bern © CBG-MEB 12 Implantable...

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Transcript of ICDRA 17 September 2008, Bern © CBG-MEB 1 17 September 2008, Bern © CBG-MEB 12 Implantable...