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COVID-19 emergency: AIFA creates “Coronavirus crisis unit”

Discussions with the technical scientific Committee on investigational drugs and off-label use

The crisis unit created by AIFA for the COVID-19 emergency is active on four main issues:

  • Drugs under off-label use. Considering that, in emergencies, hospitals use protocols providing for the off-label use of medicines marketed in Italy, AIFA is preparing the approval of those drugs already identified, that will undergo the CTS evaluation.
  • Research & Development/access to investigational drugs. Considering the feedback recorded for some pharmaceutical products under investigation, AIFA will proceed  in the next few hours to discuss at the CTS clinical studies and compassionate use for drugs containing remdevisir and tocilizumab.
  • National management guideline. Participation to the drafting of the national management guideline for the Covid-19 cases, in cooperation with the Civil Protection (CTS) and the National Institute for Infective Diseases Lazzaro Spallanzani.
  • Tackling of hospital drug shortages. AIFA is in contact with MA holders and importers regarding the regular supply of the drugs used at hospitals during the emergency, and will simplify the importation of critical products.

Moreover, in this critical phase of emergency, AIFA considers appropriate to share any information regarding the limited availability of some drugs, currently used off-label for the treatment of patients affected by the Coronavirus. This situation is generating a relevant flow of requests for those medicines under shortage or under risk of shortage, that can be obviated through the release of importation authorisations to health facilities or holders applying for it, thus ensuring the therapeutic continuity. Finally, the Agency confirms that they will promptly share any update on the progress of the medicine availability and is available for Regional Pharmaceutical Services for any further integration required.

Published on: 12 March 2020

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