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European Pharmaceutical Legislation: Industry Expectations and Impact

Explore the expectations of the pharmaceutical industry regarding the new European pharmaceutical legislation and examine the impact on patients' access to new medicines and scientific advice. Also, discover the industry's perspectives on peer review, additional data protection, and related legislations.

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European Pharmaceutical Legislation: Industry Expectations and Impact

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  1. 10th Annual European Scientific and Regulatory Affairs ConferenceNew Pharmaceutical legislation:One year experience…21 November 2006 Bernard Lemoine Leem Executive Vice-President

  2. 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

  3. 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 ?

  4. 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

  5. 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

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