Here are the main regulatory updates in the clinical field, made public between May and June in Italy and Europe.

EMA: news on CTIS, Clinical Trial Information System

EMA confirmed that the EU clinical trial portal and database Clinical Trial Information System (CTIS) is fully functional and on track to be operational by 31 January 2022. CTIS will be the only system in the EU for the submission of clinical trials. Clinical trial sponsors will only be able to request in one submission that a clinical trial be assessed in all countries of the European Economic Area (EEA) instead of having to apply separately in each country. This single application will include submission to the relevant national authorities and ethics committees for all countries involved.
The EMA Website has published the guides related to the CTIS (Clinical Trial Information System) Training Program of Modules: 13 “Clinical Study Reports submission” which explains how to create and submit the Clinical Study Report and 14 “Supervise a CT -Corrective measurese” that explains how to do and then submit corrective actions on clinical trials. Finally, the CTIS “List of Acronyms” was also published, listing the main acronyms and definitions related to the CTIS system.

EUROPEAN COMMISSION: publication of the official version of the European Medical Devic  Nomenclature (EMDN)

On the website of the European Commission was published the document MDCG 2021-6 “Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation” prepared by the Medical Device Coordination Group (MDCG) containing a series of questions and answers on clinical investigations with a medical device in the light of the new European Regulation.

We inform you that on the website of the European Commission has been published the final and official Italian version of the dell’European Medical Device Nomenclature (EMDN) and the draft of the English version. The European Commission is currently conducting a linguistic consultation on the English version of the EMDN nomenclature.

AIFA: update of the information on the documentation for submission of requests for authorisation of clinical trials, updated the List of Phase I Structures Self-certified pursuant to AIFA No. 809/2015

AIFA updated the clinical trial authorisation forms and substantive amendments. This document provides updated information on the documentation that Applicants (Promoters/Cro) must send to Aifas and Isss (in applicable cases) for submission of applications for authorisation of clinical trials and substantive Phase I, II, III and IV amendments thereto.

Publication by AIFA of the document “Chiarimenti in merito all’invio di copie di documenti clinici originali dai Centri Sperimentali Ai Promotori/Cro“.

We publish on the AIFA website the Guida alla presentazione della domanda di autorizzazione alla Sperimentazione Clinica che preveda l’utilizzo di sistemi di Intelligenza Artificiale (AI) o di Machine Learning (ML)”.
We communicate the update by AIFA of the List of Phase I Structures Self-certified pursuant to AIFA No. 809/2015 divided by Region.