September 2024
in short
On August 21, 2024, the Italian Medicines Agency published guidance on regulatory simplification and decentralization of clinical trials of medicines under Regulation (EU) No. 536/2014.
These guidelines focus on specific organizational issues in Italy and address many aspects relevant to clinical trials, including the use of service providers, cost reimbursement and compensation for clinical trial subjects, door-to-door delivery of study drugs, distribution of drugs, etc. Costs associated with investigational medicines for marketing authorization purposes and clinical trials conducted in out-of-hospital settings.
Regarding these areas, which have been discussed in several recommendation documents developed within the European network, the Italian Medicines Agency considers it appropriate to have detailed specifications for those organizational aspects that lack clear reference at national level, with the aim of ensuring that EU standards and guidelines Terms contained in or not expressly prohibited shall be correctly applied in Italy.
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