CAContact object

Italian Medicines (Drug) Agency/ Agenzia Italiana del Farmaco (AIFA)

Clinical Trial Office/ Ufficio Sperimentazione Clinica of AIFA

+39 06 5978401

+39 06 59944142

sperimentazione.clinica@aifa.gov.it

Via del Tritone 181

00187 Rome

Italy (IT)

http://www.agenziafarmaco.gov.it/en/content/clinical-trials

AIFA is operating on behalf of the:
Ministry of Health/ Ministero della salute
Dipartimento del l'innovazione
Direzione Generale dei Farmaci e Dispositivi Medici
Piazzale dell'Industria 20
00144 Roma
Phone + 39 06 59943809
E-mail: Segr.DGFDM@sanita.it
Websites: http://www.salute.gov.it/
(English version: under construction)

National Institute of Health/ Istituto Superiore di Sanità (ISS)

Phase I clinical trial Commission Secretariat at ISS

+39 06 49901

+39 06 49387118

segreteria.commac@iss.it

Viale Regina Elena, 299

00161 Rome

Italy (IT)

http://www.iss.it

AIFA collaborates with the National Institute of Health/ Istituto Superiore di Sanità (ISS) for the evaluation of studies and amendments related to phases I and I/II clinical trials.
Therefore the same documentation must be sent to AIFA and ISS.

Local CAs

For all phase II to IV clinical trials, the local CA of each clinical trial site is responsible for authorisation (that is the Legal Officer: i.e. the General Director of the Hospital or equivalent facility where the trial is conducted ).