ICDRA 17 September 2008, Bern CBG-MEB 1

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1 CBG-MEB 1

2 Regulatory systems in the changing environment Dutch Point of View Aginus A.W. Kalis Executive Director CBG-MEB 2

3 Drug Regulation in Europe 27 countries (recently 12 new member states) European Commission European Council European Parliament CBG-MEB 3

4 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 4

5 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 5

6 Distribution of (co)rapporteur allocations in EU CBG-MEB 6

7 CBG-MEB 7

8 Principles-based vs. Rule-based regulation Pogatetz is booked after a furious rant at referee Vink who awards Croatia a penalty in the 4 minute. 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... Economist. Metaphor of the day, April 21, 2008 CBG-MEB 8

9 MEB: division of workload Priorities? MEB Europe Generics (80% of applies) Innovation (20% of applies) CBG-MEB 9

10 Innovation more interesting than generics?? CBG-MEB 10

11 Advanced therapy products Combined ATP Gene therapy products Somatic cell therapy products Tissue engineered products Source: EMeA CBG-MEB 11

12 Implantable materials Stent coatings Nanoporous alumina and hydroxyapatite coatings increase biocompatibility and thus 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 12

13 Converging Technologies: Artificial Limbs Rheoknee R : joint filled with fluid with nanoparticles, with a memory CBG-MEB 13

14 Converging Technologies: Retinal prosthesis Second Sight R: array of electrodes, attached to the retina and used in conjunction with an external camera and video processing system. CBG-MEB 14

15 Converging Technologies: Treatment of cancer Targeting Imaging Therapy Monitoring in one molecule CBG-MEB 15

16 Converging Technologies: Deep Brain Stimulation Parkinson s Disease Syndrome of Gilles de la Tourette CBG-MEB 16

17 International influences CBG-MEB 17

18 Globalisation Different situations in Europe, Asia, America, Africa Quality standards (GCP, GMP) Ethical aspects Meetings contribute to awareness and mutual understanding CBG-MEB 18

19 Global discussion and quest for answers Goal: Development of global standards and practices CBG-MEB 19

20 COLLEGE TER BEOORDELING VAN GENEESMIDDELEN C B G M E B MEDICINES EVALUATION BOARD CBG-MEB 20