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Clinical Trials

In Italy the clinical trials are regulated by a legislative decree, entered into force in January 2004 (Decreto legislativo 24 giugno 2003, n.211).

This decree transposes the Directive 2001/20/EC concerning the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.

The above mentioned decree has integrally implemented the European directive and has also anticipated a few additional provisions issued in order to better regulate the responsibility and the role of the Ethics Committees and to give instructions about the type of information to be submitted through the database of the Osservatorio Nazionale della Sperimentazione Clinica (OsSC) - (National Monitoring Centre of Clinical Trials).
The annual number of clinical trials in Italy since 2000 has steadily grown. Since 2000 the “Annual Reports on clinical trials” are public available.

Submission procedures 

The submission of the clinical trial application data and supporting documents must be done through theOsSC Database. The sponsor must submit these data mainly in Italian except for free text core data set, where English language is required. Information required are compliant with the Ministerial decree 21st December 2007 Modalità di inoltro della richiesta di autorizzazione all’Autorità competente, per la comunicazione di emendamenti sostanziali e la dichiarazione di conclusione della sperimentazione clinica e per la richiesta di parere al comitato etico.
To access the OsSC, the sponsor/C.R.O. should obtain a user ID/password.

To request the user ID/password, it is necessary to connect with the web-site of OsSC and follow the instructions.

The registration of the trial data and documents within the OsSC complies with the Italian and European requirements (EudraCT DB) for Clinical Trial electronic data transmission to the Competent Authority.

For further details, please consult the Help section.

Competent Authorities

The Italian Medicines Agency (AIFA) is the Competent Authority (Law no. 189 of November 8, 2012) for issuing the authorization of all clinical trials of medicinal products as of Legislative Decree no. 211 of June 24, 2003, from Phase I to IV.

The expertise in the field of clinical trials of medicinal products previously granted to the National Institute of Health (ISS) by Legislative Decree no. 211 of June 24, 2003, are transferred to AIFA; ISS supports AIFA in performing the transferred functions.

Application forms and supporting documents (phases II - IV) have to be sent to the Ufficio Ricerca e Sperimentazione Clinica of AIFA.

Since AIFA collaborates with ISS for the evaluation of studies and amendments related to phases I and I/II, the same documentation must be sent to AIFA and to the Phase I clinical trial Commission Secretariat at the National Institute of Health (ISS) (Viale Regina Elena, 299 - 00161 Roma).

Further information and contact details are available at the following links:

Contacts

AIFA
Ufficio Ricerca e Sperimentazione Clinica
Via del Tritone, 181
00187 Roma - Italy
E-mail: sperimentazione.clinica@aifa.gov.it

Istituto Superiore di Sanità
Dipartimento del farmaco
V.le Regina Elena, 299
00161 Roma - Italy
E-mail: segreteria.commac@iss.it

For initiating a trial in Italy it is necessary to submit the application to AIFA for receiving  the authorization and also to the Ethics Committees competent for the clinical sites for their formal approval.

The study should also be notified to the Director General of the healthcare institution for the contract definition.

For all the clinical trials (except for phase I and trials testing gene/somatic cells/GMO therapies whose deadlines are indicated in Art.9 of Legislative Decree 211/2003) the  Competent Authority can authorise the trial within 60 days. If the Competent Authority has not informed the applicant of any grounds for non-acceptance within 60 days, the trial is considered authorised, provided that the opinion of the Ethics Committee is favourable. Timeframe is reduced to 35 days for the authorisation/no grounds for non acceptance of any substantial amendment

For the fulfillment of legal obligations regarding the reporting of SUSARs, with effect from February 1, 2014, Sponsors, or delegated Contract Research Organizations (CROs), are required to send SUSARs only to the EudraVigilance Clinical Trial Module (EVCTM).

 

Foto di Sandra Petraglia

Pre-Authorization Department

Head of office: Sandra Petraglia
E-mail: s.petraglia@aifa.gov.it

 

Foto di Donatella Gramaglia

Clinical Trials Office

Head of office: Donatella Gramaglia
E-mail: d.gramaglia@aifa.gov.it

Data aggiornamento: August 2017
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