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10th Annual European Scientific and Regulatory Affairs Conference
New Pharmaceutical legislation: One year experience…
21 November 2006
Bernard LemoineLeem Executive Vice-President
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One year after starting the implementation of the new European pharmaceutical legislation,
What are the expectations of the pharmaceutical industry ?
• Speed up patients access to new medicines
• Improve scientific advice in terms of timelines and procedure
• Get therapeutic innovation recognized
• Strengthen transparency and consistency of EMEA procedures
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Does EMEA meet Industry expectations ?
In terms of regulatory tools : relating to
- Accelerated assessment procedure
- Conditional marketing authorisation
- Decentralised procedure
- Compassionate use
What about scientific advice ?
What is requested for being granted an additional year of
data protection ?
What about the scope of the Peer review ?
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With regard to other legislations
First, the one related to the -soon to be- regulation on paediatric
medicines
- France initiated this Regulation
- The Leem strongly supports the development of new paediatric medicines
- Pharmaceutical industry is much keen to see how EMEA will implement the Paediatric
Committee, the procedures and incentives measures
- National incentives are much awaited mainly in France in terms of R&D policy and price
setting
Second the legislation related to the Directive on clinical trials
- The new legislation took effect in France, in August 2006, implementation process much
efficient through fruitful close cooperation between AFSSAPS and Pharma Industry
- Yet resulting in redtape and various interpretations by Member States
- Therefore need for simplification and harmonisation
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In conclusion, what about the impact of these new regulations ?
• Contribute to
strengthening harmonisation of procedures in Member States
improving pharmaceutical industry efficiency facilitating patient access to innovative medicines in the best efficient and quickest manner