The work that the Istituto Superiore di Sanità (ISS, the National Institute of Health in Italy) carries out in the field of medicines, including vaccines and advanced therapies, is multiple and covers all stages of the process, from the moment they are conceived and developed through laboratory research, through the clinical trial period and their subsequent use by citizens for both prophylactic and therapeutic purposes.
The ISS activity takes place at two different levels. The first relates to the design, control, evaluation and testing of drugs before they are put on the market. This level includes laboratory research to develop new therapeutic strategies, testing experimental hypotheses by way of preclinical and clinical trials, defining drug quality, evaluation (both preclinical and clinical, with particular reference to phase I clinical trial) by external bodies, verification of compliance of quality parameters to the current rules, as well as providing support to the Italian Medicines Agency (AIFA) in the final stages of the development process when the drug obtains the Authorization for Marketing (AIC) at the national or international level (EMA, European Medicines Agency).
The second level of activity relates to drugs already on the market. At this stage the ISS continues to monitor the quality of drugs that are already available to patients, and to combat drug counterfeiting activities. In addition,the ISS, alongside its role in surveillance and pharmacovigilance, conducts pharmaco-epidemiological research on the efficacy and safety of drugs as data becomes available after commercialization, contributing to the constant monitoring of drug effects on the population.