摘要：The drug evaluation process is one of the most important
challenges for regulatory agencies and public
research institutions. As the Istituto Superiore di
Sanità (ISS), which is the National Health Institute,
our main mission in the field of drugs (and, in general,
of medicinal products) is to guarantee the safety and
the efficacy of drugs in order to protect public health.
At the same time, however, we do have the precise duty
to promote public health and to favor the translation
of new treatments to the patients who need them.
In the last few years, however, the discovery of new
disease-ameliorating molecules has been frustratingly
poor. At a time when basic biomedical knowledge is
dramatically increasing, the gap between bench discovery
and bedside application appears to be expanding.
This means that fewer new products can be approved
and made available to patients
