24
Feb
AIFA stops all clinical trials that do not comply with the Clinical Trials Regulation on January 31, 2025
According to the EU Regulation on Clinical Trials (CTR), for the first 3 years from the application of the CTR, trials could be conducted in Europe according to the CTR or according to the previous legislation, depending on when the request for authorization to conduct the trial was submitted.
21
Nov 24
New AIFA guidelines on simplification and decentralization of clinical trials
The AIFA approved guidelines concerning simplification and decentralization of clinical trials of medicines, on the same day as those on observational studies.
21
Nov 24
New AIFA guidelines on observational studies and decentralized clinical trials: Digital tools increasingly in focus
The AIFA issued two new guidelines, focusing, respectively, on observational studies and clinical trials for medicinal products.
Clinical investigations on medical devices: four ministerial decrees setting out procedures for submitting applications/notifications and requirements for facilities and assessing persons, implementing Lgs. D. 137/2022, were published on 13 and 14 June.
Clinical investigations on medical devices: four ministerial decrees setting out procedures for submitting applications/notifications and requirements for facilities and assessing persons, implementing Lgs. D. 137/2022, were published on 13 and 14 June.
4
Apr 23
Decentralized clinical trials: Recommendation paper for the implementation of uniform procedures in the European Union published
On December 13, the long-waited European Recommendation paper on decentralised elements in clinical trials was finally published, to provide Member States further and more detailed guidance on the implementation of procedures for conducting trials outside of clinical trial centers.
2
Feb 23
New decrees for the reorganization of ethics committees have been signed: The last fundamental steps for operation of the CTR in Italy
On January 30, the Ministry of Health finally signed four ministerial decrees that mark fundamental turning points in the construction of a regulatory framework for the European Clinical Trials Regulation (“CTR”) to become operations.
