The AIFA has indicated that in the event of difficulties due to the emergency of covid 19, the mandatory entry of data on drug treatments monitored by the AIFA registry on the web can be postponed to a maximum of 90 days from 12 March 2020. This measure applies only to patients already on treatment registered on the AIFA platform and, in all cases, the launch of new treatments and innovative drug registers (according to Article 1, paragraph 404, of Law 232/2016 and available at the web address: www.aifa.gov.it/farmaci-innovativi). Home > the European Union > The Italian Pharmaceutical Agency publishes guidelines for the management of clinical trials in Italy during the emergency AIFA COVID 19, approval of the TOCIVID-19 study, which will renovate the efficacy and safety of tocilizumab in the treatment of pneumonia. The study is funded by the National Institute for Cancer Research and Treatment in Naples, with the University of Modena and Reggio Emilia and the IRCCS of Reggio Emilia, as well as with the Technical Scientific Committee of AIFA. All the clinical centers that request it participate in the study and are managed by the promoter`s web platform (Institut Pascale de Naples). Details of the study are available on the AIFA website. The guidelines cover all phases of clinical trials, i.e. the introduction of applications for approval for clinical trials; Evaluation of ethics committees; Management of clinical trials outside control centres. The guidelines also contain some exceptions to the current EU and Italian legislation, namely the management of the test drug; Closing a clinical trial site Clinical trials; monitoring clinical trials Reimbursement of one-off expenses Sponsors can enter into agreements directly with specialized agencies on the conduct of activities related to patient care. More details can be found below.
Introduction Applications and Amendments Ethics Committees Management of Experimental Activity Outside the TRIAL Sites of IMP Clinical Tests for Patients Study Sites, on 7 April 2020, the Italian Medicines Agency (AIFA) announced that it had made its recommendations (hereinafter referred to as recommendations) on the management of clinical trials during COVID-19 (“coronavirus”), on request.