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
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
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.
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization procedure and (iii) regulate the transitional period for evaluation activities
21
Dec 22
Clinical trials and sanctions in relation to Regulation 2014/536, national rules, and contract standards
The European rules on drug trials do not include provisions for sanctions, but instead leave it up to Member States to outline an effective sanctioning framework.
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
