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Report Clinical Trials of Drugs in Italy 2015

Number of pages: 37
Date: 09/02/2016

As in previous years, the final section of the National Report on clinical trials concerns the legislation updating.

Only one provision has been introduced in 2014, the year this report refers to. Nevertheless, the importance of this measure at a national and international level, not only in Europe, is likely to be reflected on the entire report and the entire Italian research system with an impact that will be perhaps even greater than the one subsequent to the Pharmacovigilance legislation introduced in 2012, at that time defined as a tsunami. 2014 was indeed the year of the publication and entry into force of Regulation 536/2014, which gave clear indications - in its final version - on how the clinical research will have to be reorganized in Europe and, consequently, in Italy, during the next few years.

The clinical trials’ evaluation at the national level will be replaced by a co-ordinated management at the European level: this will require the application of shared standards and procedures and the consequent need to rethink criteria and mechanisms currently in force in the planning and evaluation of pharmacological clinical trials.

Stakeholders are already considering how to adapt their strategies and organizations to meet the requirements of the new Regulation, and also the Member States are actively working to program the necessary reorganizations nationwide.

The data of the past year are therefore essential food for thought in the planning of the change to be put in place over the next two years.

Data aggiornamento: February 2016
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