EU Council Adopts EFPIA Joint Technology Initiative on Innovative Medicines

GMP News
6 February 2008

EU Council Adopts EFPIA Joint Technology Initiative
on Innovative Medicines

The Council adopted a regulation establishing a Joint Technology Initiative (JTI) aimed at implementing research projects in innovative medicines, intended to strengthen the European pharmaceutical sector by accelerating the development of safe and more effective medicines for patients. The maximum Community contribution to both the research activities and the running costs for the period up to 2013 is set at EUR 1 billion.

The so-called Innovative Medicines Initiative ("IMI") is a unique public-private partnership between the pharmaceutical industry represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Communities represented by the European Commission.

The initiative will give pharmaceutical companies the possibility to collaborate and to find solutions for challenges in the biopharmaceutical drug development process which might be summarised as:

  • Insufficient R&D investment
  • Technological complexity
  • Fragmented Research in Europe

The IMI stakeholders' Strategic Research Agenda identifies the principal research bottlenecks in the biopharmaceutical R&D process and sets forth recommendations to overcome these bottlenecks by focusing on four areas:

  • Predicting safety
  • Predicting efficacy
  • Knowledge management
  • Education and training

Both knowledge management and education & training aim to improve the information flow between the different phases of the drug development process.

Source and more information:  (EFPIA-IMI website) and

Ensuring cGMP Compliance in the Process Development for Biotechnological Processes will be on e topic at the
ECA Good Development Practice Conference in Berlin, Germany, from 22-24 April 2008.
Hear representatives from European authorities and the FDA as well as specialists from the pharmaceutical industry share their expert knowledge about important aspects of Pharmaceutical Development and IMP Manufacturing.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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