AIFA - ISS - ASSOBIOTEC SIGN AN AGREEMENT TO STIMULATE THE CLINICAL TRIALS IN THE FIELD OF BIOTECHNOLOGY IN ITALY
October 01, 2012
Milan, October 1st 2012 - The Director General of AIFA (Agenzia Italiana del Farmaco) prof. Luca Pani, the President ISS (Istituto Superiore di Sanità), prof. Enrico Garaci, and the Director of Assobiotec, Italian Association for the Developement of Biotecnology, dr. Leonardo Vingiani, signed today at the headquarters of AIFA, the "Planning Document to encourage clinical trials in the field of Biotechnology in Italy."
"This is a practical tool to revive the Italian research and to attract investments into the country" said Leonardo Vingiani, Director of Assobiotec. "With this agreement we intend to take measures to strengthen the Italian capability to attract precious resources and know-how. Those arising from the biopharmaceutical companies intending to carry out early stage clinical trials, that allow the country to increase knowledge and scientific competences at national level. We have a huge potential: Italy has in fact several products in clinical development, and many other in discovery and preclinical phase that in the coming months will be able to get to the clinic, and we want them to do it in Italy."
The objective of the agreement is to identify measures and procedures to encourage and facilitate the introduction of an increasing number of clinical trials of early stage (I and II) in Italy. In the program document are outlined a series of measures that will be implemented for a trial period of 12 months. In particular, the agreement provides:
- the AIFA commitment to ensure a faster path in the establishment of the remboursement price for the companies that make early stage clinical trials in Italy;
- the AIFA commitment to run training courses for personnel involved in the preparation of the dossier "Clinical Trial Application";
- the AIFA commitment to carry out inspections within a short time, so that sites can produce the new product as intended by the GMP. AIFA will create a special technical team to identify specific priority criteria in order to facilitate inspections allowing companies to produce new products to start the clinical trials;
- the ISS commitment to ensure time standards for the evaluation of clinical Phase I and prompt free pre-submission hearings to better support dossier preparation (Clinical Trial Application) by the Promoters of clinical research;
- the ISS commitment to eliminate, for companies that have not yet marketed drugs, the expected authorization fee for phase I;
- the Assobiotec commitment to actively promote the agreement with biotech companies operating in Italy, to increase over the next three years, the number of early stage clinical trials (I and II) conducted by firms in the country at least of 30%.