On May 8, 2019, the Council of Ministers approved one of the decrees implementing Law No. 3/2018, by which the government was delegated, inter alia, to reorganize the existing legislation on clinical trials on medicinal products for human use.   

Among the various changes introduced by the decree, we note the following:

  • The obligation for centres using IT systems to support clinical trials to use specific professionals for the management of data in compliance with European and national privacy legislation
  • The introduction of discounted fees for inspections of good clinical practice on phase I studies adopting a methodological approach in favour of gender medicine
  • The adoption, by the Italian Institute of Health, of guidelines aimed at simplifying the procedures for the use of residual biological or clinical material from previous diagnostic or therapeutic activities for clinical research purposes
  • The obligation for promoters of non-profit observational clinical studies and clinical trials to reimburse direct and indirect costs related to the trial, any loss of income resulting from the qualification of the study as non-profit activity, including potential revenues related to the exploitation of the intellectual property
  • The publication by the Italian Medicines Agency of the list of centres authorized to conduct clinical trials
  • The issuance by the Ministry of Health of a decree establishing the suitability requirements applicable to centres where clinical trials are conducted
  • The identification by the Italian Medicines Agency of methods suitable to protect the independence of clinical trials and ensure the absence of conflicts of interest in the assessment of the relevant applications
  • The adoption, through a decree of the Ministry of Health, of new procedures for the assessment and authorization of clinical trials aimed at involving patient associations