Framework Agreements on Research & Development

The Italian Medicines Agency promotes at national level investment in production, research and development in the pharmaceutical sector, according to the ten-year European Union Programme of renewal and encouragement of the economic and social environment as defined by the Lisbon European Council.

Framework Agreements are intended for pharmaceutical companies operating in the Italian territory, which are selected for admission to the funding through a specific call for proposals.

Investment is destined to:

• The promotion of phase I and II clinical trials in Italy 
• The promotion of Pre-clinical Research
• The establishment or expansion of production sites
• All the proposal should provide hiring of new:
  • permanent staff involved in  production
  • permanent staff assigned to R&D activities.

AIFA launched a call for proposal in 2008 with a funding amounting to a total of € 100 million.

51 Companies submitted proposals for 141 projects.

For the assessment of the proposals, AIFA appointed a special Commission with relevant multidisciplinary pharmaco-clinical skills and experience in economics, which assessed investment projects, on the basis of specific indicators developed by the Commission itself, in accordance with the call for proposals.

In three months the Commission completed its evaluation process and established a list of the most interesting projects to be funded. The shortlist was subsequently approved by the AIFA Managing Board and published.

At the time being, the Agency is monitoring technical and administrative progress of the financed projects.