[Drug evaluation: new requirements and perspectives]

Lately the European and international regulatory Agencies, responsible for the evaluation of drugs, have not been capable to implement regulatory processes guiding clinical practice efficiently. The sudden withdrawal of innovative drugs, the incapacity of assuring independence, the not controlled trend of pharmaceutical expenditure are signals of the failure of a system which should respond to the mandate of public health and market regulation. Some intrinsic limits of present regulatory systems arise because regulatory Agencies approve medicinal products on the basis of minimum standards of efficacy or owing to fast registration procedures which do not allow to assure the real efficacy and safety of the product approved. Non-inferiority and equivalence trials, short duration studies conducted on small populations (not representing the real setting of utilization in clinical practice) are often considered sufficient for drug registration. Moreover, Agencies often lack data on the safety of approved products and based on post-marketing surveillance and monitoring plans which can assure the real profile of drug safety. Owing to the institution of the Italian Medicines Agency (AIFA), Italy has lately approached European standards of regulation and proposed a new original regulatory approach attempting to go beyond some of the main limitations described above. The main points the model is based on are: promotion of use appropriateness through the analysis of experiences occurring in the area; promotion of independent drug research in order to collect data reliable and useful for drug regulation; publication and distribution of independent information on drug utilization for health professionals. The Italian approach tries to bring regulatory provisions close to clinical practice by promoting a correct and rational use of drugs and developing new areas of intervention for research, vigilance and information.