Italian Medicines Agency Agenzia Italiana del Farmaco

Inspections and authorisations


AIFA guarantees Good Clinical Practice (GCP) inspections on clinical trials concerning medicinal products, the inspections’ follow up, and the implementation of GCP rules and guidelines. It supervises and monitors the manufacturing sites of pharmaceutical companies, in order to ensure quality in the manufacturing of medicinal products and raw materials (GMP). The Agency verifies the implementation of European and national legislation concerning distribution, importation, export as well as the proper functioning of early alert and emergency management procedures. It also ensures that there is equivalence between the Italian and the EU Member States’ inspection systems, and in the context of the mutual recognition agreements.

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