Osteoporosis International

, Volume 19, Issue 6, pp 725–731

European regulatory perspectives for innovative therapies


DOI: 10.1007/s00198-008-0576-4

Cite this article as:
Ormarsdottir, S., Reginster, J. & Abadie, E. Osteoporos Int (2008) 19: 725. doi:10.1007/s00198-008-0576-4


The current regulatory requirements offer accelerated assessment of innovative therapies in Europe. Future perspectives include the need for increased interaction between stakeholders in pharmaceutical development. Development of new, high quality, effective and safe medicines in Europe is the common goal of academia, pharmaceutical industry and regulatory authorities. To achieve this, it is important that regulatory requirements do not hinder innovation and vice versa, innovation cannot be allowed to proceed without concerns for public health. Interaction between stakeholders in pharmaceutical development is of the utmost importance. A dialogue has begun and in the future it will be the responsibility of all stakeholders to ensure continuous exchanges in an environment that is characterised by new scientific advances and global development programmes.


AcademiaDrug developmentEuropean Medicines AgencyInnovative medicinesPharmaceutical industryRegulatory requirements

Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2008

Authors and Affiliations

  1. 1.CHMP member, Senior ExpertIcelandic Medicines Control AgencySeltjarnarnesIceland
  2. 2.President, European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO);  
  3. 3.President, Group for the Respect of Ethics and Excellence in Science (GREES); CHMP ExpertLiegeBelgium
  4. 4.CHMP chair, EMEA and Scientific Advisor, General DirectorateAFSSAPSSaint-DenisFrance
  5. 5.Bone and Cartilage Metabolism Research UnitLiegeBelgium