Pharmacovigilance services in Italy

The Italian Ministry of Health and the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) is responsible for overseeing all regulatory and pharmacovigilance services. for pharmaceutical products that are in circulation in the country. The AIFA is the national authority responsible for drug regulation in Italy. AIFA collaborates with other organizations and committees i.e., the National Institute of Health, research institutes, patient’s associations, healthcare professionals, scientific societies, the pharmaceutical industry and distributors. The mission of the AIFA in pharmacovigilance is to ensure a positive risk/benefits ratio for all authorized drugs through the continuous monitoring of all safety information and ADRs. Marketing Authorization Holders (MAHs) must appoint a qualified person responsible for pharmacovigilance (QPPV) for ADRs reports management. All the reports of adverse reactions will merge into the European database EudraVigilance, and this activity is aimed at the identification of changes in risk or new risks through signal analysis. Although Italy has a good system and robust structure, it could be improved as too many differences exist between regional and local activities. Physicians and healthcare professionals are required to report all suspected serious/ or unexpected ADRs which they learn from their activity to improve the system.

As a leading global contender, DDReg understands the significance of patient safety right from spontaneous to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Italy that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.