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Practically, the local CA performs the administrative evaluation of the financial agreement and usually delegates the complete scientific assessment of the trial to the EC of its facility.
The central CA (AIFA) performs only a marginal assessment of all the clinical trials employing therapies which do not fall within its competence involving only a check of the data before transmission to EudraCT database and a check of suspected serious adverse reactions (SUSARs). The assessment of the complete clinical trial application and documents is performed by certified ECs.

Article 2 t) of Legislative Decree 211/2003 defines the following competent authority for clinical trial on a medicinal product for human use:
1) Local CA: The General Director or Legal Officer, pursuant to current legislation, of the public health facilities at which the clinical trial is conducted, or equivalent facilities, as defined by decree of the Minister of Health;
2) National CA: The Italian Drug Agency on behalf of the Ministry of Health:
a) in the cases referred to in Part A of the Annex to Regulation (EEC) No. 2309/93, and other medicinal products with special characteristics, such as medicinal products the active ingredient or active ingredients of which is or are a biological product or biological products of human or animal origin, or contains biological components of human or animal origin, or the manufacturing of which requires such components.
b) in relation to the medicinal products for gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing genetically modified organisms. No gene therapy trials may be carried out which result in modifications to the subject’s germ line genetic identity.
3) The National Institute of Health in the case of the newly instituted drugs referred to in Presidential Decree no. 43 of 21 September 2001 and for phase I trials in general.