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Agenzia Italiana del Farmaco
Pharmacovigilance
Pharmacovigilance is the set of activities aimed at conributing to the protection of public health. They are activities directed toward identifying, assessing, understanding and preventing adverse effects or any other problem related to the use of medicines, in order to ensure a favourable benefit/risk ratio for the population.
Data on medicine safety can be derived from multiple sources: Reports of suspected adverse reactions (spontaneous and non-spontaneous), clinical trials, scientific literature, reports from pharmaceutical industries, etc.
AIFA promotes active pharmacovigilance programmes and studies with the aim of increasing knowledge on medicines and better defining the safety profile in relation to their use, improving how they are used, establishing a safety profile that best corresponds to clinical practice, and more realistically describing the characteristics of patients undergoing treatment.
The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines, which are authorised in EU.
The PRAC was formally established in 2012 and consists of 2 members representative of EU Member States/European Economic Area, 6 members appointed by the European Commission with relevant expertise in safety of medicines and pharmacovigilance, and 2 representatives, respectively, of healthcare professionals and patients.
The mandate of the PRAC shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, assessment, minimisation and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance audit.
The procedures related to each medicinal product are evaluated by two Member States acting as Rapporteur and Co-Rapporteur, with the participation of all the other members of the Committee. The PRAC meets once a month. PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the Committee for Medicinal Products for Human Use (CHMP) for centrally authorised medicines and referral procedures; to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) on the use of a medicine in Member States.
National matters not involving other Member States and having no impact at European level are discussed and managed within AIFA’s Support and Coordination Secretariats and Advisory Committees (https://www.aifa.gov.it/segretariati-di-supporto-e-coordinamento-e-comitati-consultivi).
