Clinical_trials_Regulation

The Italian Minister of Health has signed the four decrees on Ethics Committees, thus taking a decisive step towards the full implementation in the Italian legal system of the European Regulation 536/2014 on clinical trials.

By Decree of the Minister of Health on January 26, 2023, with prior agreement in the State-Regions Conference, the number of the territorial Ethics Committees is now 40 instead of the previous 80-90. The Committees are identified and have the task of evaluating clinical trials on medical devices and medicines for human use.

Another important measure long awaited and decisive in terms of administrative simplification, is the decree, adopted by the Minister of Health in agreement with the Minister of Economy and Finance, determining the single fee for clinical trials.

More information about this news is available here.

 

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By Published On: February 3rd, 2023Categories: News0 Comments