AIFA, COVID-19 emergency: "Coronavirus crisis unit" set up
Comparison with the Technical-Scientific Committee on experimental drugs and off-label uses
The crisis unit set up by AIFA for the COVID-19 emergency is engaged in four main lines:
- Drugs in use "off label". In consideration of the fact that in the emergency hospitals resort to protocols that provide for the off-label use of medicines on the market in Italy, AIFA is preparing the approval of those already identified, which will be subjected to evaluation by the CTS
Research and development/access to investigational drugs. In consideration of the findings recorded for some pharmaceutical products under investigation, AIFA will already proceed in the next few hours with the discussion in the CTS regarding clinical trials and compassionate uses for the drugs based on remdevisir and tocilizumab- National management guideline. Participation in the development of the national management guideline, relating to the cases of Covid-19, in collaboration with the Civil Protection (CTS) and INMI Lazzaro Spallanzani
- Tackling medicine shortages at hospital level. AIFA is in contact with MA holders and importers regarding the regularity of supplies of medicines used in hospitals during the emergency, and proceeds to facilitate the importation of critical products.
Furthermore, AIFA, in this emergency phase, deems it appropriate to share information regarding the limited availability of some drugs, currently used off-label for the treatment of patients with Coronavirus. This situation is generating a significant flow of requests for those medicines that are lacking or at risk of lacking, which can be compensated for by issuing import authorizations to healthcare facilities or holders who request them, thus guaranteeing the continuity of therapies. Lastly, the Agency, in confirming that it will take care of promptly sharing any updates on the evolution regarding the availability of medicines, remains at the disposal of the Regional Pharmaceutical Services for any further integration needed.
AIFA – Published on: 12 March 2020
Communication: AIFA, COVID-19 emergency: "Coronavirus crisis unit" set up [0.18 Mb] >
Determine DG n. 256/2020 [1.19 Mb] >
