Claudia Garimberti -

The conduct of Clinical Trials on medicinal products in Italy is subject to authorization by the Competent Authority (i.e. Agenzia Italiana del Farmaco – AIFA) and positive opinion by the Ethics Committee(s) to which the involved clinical site(s) refer.

In case of multiple clinical sites in Italy, the Ethics Committee to which the Coordinating Investigator refers shall be considered the “Coordinating EC”. The Ethics Committees to which other Investigators refer shall be considered “satellite” ECs and shall only accept or refuse the opinion issued by the coordinating EC.

In case of phase I Clinical Trials and Trials involving Advanced Therapy Medicinal Products (ATMP) a formal, written authorisation from the Competent Authority AIFA and a positive opinion from the competent Ethics Committee(s) must always be awaited (for both initial CTAs and amendments).

In case of all other phase II, III and IV Clinical Trials, the Sponsor can start the Trial/implement the amendment only after receiving written positive opinion of the competent EC and only if AIFA has not communicated any motivated objection within the relevant regulatory timelines, different depending on the type of application (i.e. initial CTAs or substantial amendments).

Clinical Trial Applications and amendment applications to AIFA and the Ethics Committees must be managed through the web-based platform “Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali”, which is available in Italian language only and allows to interact with the authorities and monitor the progression of the authorization phase.

 

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