Italian Medicines Agency Agenzia Italiana del Farmaco

Quality and Inspections

Quality and Inspections

AIFA 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 monitors and checks that good clinical practice (GCP) standards are followed when conducting clinical trials, and ensures that there is equivalence between the Italian and the EU Member States’ inspection systems, and in the context of the mutual recognition agreements with Canada and the US. The Agency supervises and monitors the pharmacovigilance systems of marketing authorisation holders (MAH).

The quality of medicinal products available on the market is also ensured through the management of reports regarding the presence of defects in one or more batches of medicinal products or raw materials.

Reports of quality defects are sent by private and public pharmacies, territorial (local health authorities) or hospital pharmacies, healthcare professionals, manufacturing companies, MAHs, the National Health Institute, the European Medicines Agency and national competent authorities of EU Member States with whom mutual recognition agreements are in place.

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