A. whereas the Innovative Medicines Initiative Joint Undertaking ("the Joint Undertaking") was set up in December 2007 for a period of 10 years to significantly improve the efficiency and effectiveness of the drug development process with the long-term aim that the pharmaceutical sector produces more effective and safer innovative medicines,

A. whereas the Innovative Medicines Initiative Joint Undertaking ("the Joint Undertaking") was set up in December 2007 for a period of 10 years to significantly improve the efficiency and effectiveness of the drug development process with the long-term aim that the pharmaceutical sector produces more effective and safer innovative medicines,

A. whereas the Innovative Medicines Initiative Joint Undertaking (‘the Joint Undertaking’) was set up in December 2007 for a period of 10 years to significantly improve the efficiency and effectiveness of the drug development process with the long-term aim that the pharmaceutical sector produces more effective and safer innovative medicines,

Action n° 6: To promote, in a staged approach, unprecedented collaborative research and development efforts to bring new antibiotics to patients by: Launching rapidly with EFPIA[12], within the IMI-Joint Undertaking, a programme for research on new antibiotics aimed at improving the efficiency of research and development of new antibiotics through unprecedented open sharing of knowledge. Establishing an overarching framework agreement with the industry, defining objectives, commitments, priorities, principles and modes of action for public-private collaboration in a longer term perspective. Mobilising adequate resour ...[+++]ces, within IMI in particular (and its possible successor), FP7 and in the longer term the forthcoming research and innovation programme 2014-2020 (Horizon 2020), in order to support research and development work, based on criteria and modalities adapted to the specific needs and challenges of antibiotic development. Use the flexibility in the current pharmaceutical legislation to give rapid authorisation to new antibiotics and work with stakeholders and the Member States' authorities towards the establishment of adequate market and pricing conditions for new antibiotics. Ensure conditions for and implement fast track procedures for the marketing authorisation of new antimicrobials.

Risk factors that may be considered include: the origin of the cells (autologous, allogeneic, xenogeneic), the ability to proliferate and/or differentiate and to initiate an immune response, the level of cell manipulation, the combination of cells with bioactive molecules or structural materials, the nature of the gene therapy medicinal products, the extent of replication competence of viruses or micro-organisms used in vivo, the level of integration of nucleic acids sequences or genes into the genome, the long time functionality, ...[+++] the risk of oncogenicity and the mode of administration or use.

Risk factors that may be considered include: the origin of the cells (autologous, allogeneic, xenogeneic), the ability to proliferate and/or differentiate and to initiate an immune response, the level of cell manipulation, the combination of cells with bioactive molecules or structural materials, the nature of the gene therapy medicinal products, the extent of replication competence of viruses or micro-organisms used in vivo, the level of integration of nucleic acids sequences or genes into the genome, the long time functionality, ...[+++] the risk of oncogenicity and the mode of administration or use.