The Italian Medicines Authority (“AIFA”) has recently issued new guidelines for the classification and conduct of observational studies on medicines (“Guidelines”) repealing the previous version of 2008. Through such new Guidelines AIFA has given full implementation to what was provided for in Article 6, par. 3 of the Ministry of Health November 30, 2021 decree, which had mandated that AIFA issues new guidelines for the classification and conduct of observational studies on medicine.

The new Guidelines have extended the perimeter of observational studies and now include:

• Retrospective studies related to unauthorized uses;
• Pharmacogenetics and pharmacogenomics studies;
• Databases and other data on drug therapies collected through online platforms, wearables, or other devices when the following conditions are met:
  1. They pursue the aim of keeping track of the medicines used by patients;
  2. They follow a specific protocol;
  3. They are carried out in accordance with Guidelines’ indications.

Other new elements introduced by the Guidelines are:

• The duty for ethics committees, in case of non-profit observational studies, to verify the independence from commercial promoters;
• The duty to insert a specific section on informed consent in the protocol;
• The duty to publish the results of the research (even if they are negative) within 12 months from the end of the study;
• The duty to retain documents on observational studies for 7 years;
• The possibility for the territorial ethics committee to apply a fee on profit observational studies;
• The inclusion of universities among facilities where observational studies can be carried out;
• The inclusion of new documents that the promoters must submit to ethics committee, such as a cover letter with the precise identification of the competent ethics committee, a summary of the protocol, and investigators/coordinators’ curricula; 
• The duty of the legal representative of the research centre to execute an administrative agreement prior to the start of the study.

The Guidelines confirm that there is no mandatory AIFA assessment on observational studies, even though the ethics committee may decide to consult AIFA if necessary. The Guidelines also confirm the duty to transmit the information on the studies to the “Registry of observational studies” run by AIFA.

The definition of observational studies has not changed, i.e., studies that meet the following conditions:

• Medicines are prescribed and delivered according to the conditions of use authorized for marketing in Italy;
• Medicines are prescribed in the normal clinical practice;
• The decision to prescribe the medicine to the patient must precede and be independent with the decision to include the patient in the study;
• Diagnostic and evaluative procedures correspond to the current clinical practice without leading to negative consequences for the patient or the National Healthcare System.