Covid-19 in Italia: procedure semplificate per farmaci e sperimentazioni cliniche

In the context of the COVID-19 emergency, both the Council of Ministers and the Italian Regulator (AIFA - Agenzia Italiana del Farmaco) have issued some measures mainly aimed at streamlining the authorization processes and also at allowing a centralized and uniform management of the various needs of the healthcare system.

1. National coordination measures

Appropriate measures have been taken in order to carry out a national coordination of clinical trials on patients with COVID-19.

To this purpose, the Ethics Committee of the National Institute for Infectious Diseases “Lazzaro Spallanzani” in Rome, has been appointed as the National Unique Ethics Committee for the evaluation of clinical trials of medicines for human use and medical devices for patients with COVID-19.

Spallanzani's Ethics Committee will therefore express a national opinion, also on the basis of the evaluation of the AIFA Technical Scientific Committee.

The Ethics Committee may also collect from the promoters all the protocols of the clinical trials on medicines on phase II, III and IV for the treatment of patients with COVID-19, as well as the requests from doctors on compassionate use programs.

1. Simplification of administrative procedures

In order to guarantee a more efficient and coordinated management of the various requests for the activation of clinical trials and compassionate use of medicines for the treatment of patients affected by the COVID 19 virus, AIFA has introduced a fast track for the transmission of documentation by companies.

In particular, in cases where the legislation would require the transmission of documents in paper format, submission of request for authorization for clinical trials relating to the treatment of COVID-19 will instead be possible 19 by sending the application to the email address apa@pec.aifa.gov.it, attaching the documentation to the email or using a cloud.

In addition, considering that many pharmaceutical companies, non-profit promoters and CRO have, due to the emergency, applied or extended the smart-working method. AIFA has issued other measures applicable to all clinical trials

On this regard, the applications submitted via OsSC, the applicants are allowed to defer the sending of paper documents and CDs, which in any case must be sent as soon as possible to the Clinical Trials Office.