The European Pharmacovigilance Regulation 1235/2010 significantly changed the legal basis for pharmacovigilance in the European Union by introducing new tools and procedures to improve the effectiveness and rational use of medicines safety monitoring. It also promoted transparent decision-making and defined ways to increase citizen participation. These changes have had a significant impact on the roles and responsibilities of all stakeholders involved in pharmacovigilance, i.e. AIFA as the regulatory agency, the pharmaceutical industry, healthcare professionals and citizens.

Directives of the European Parliament and of the Council 2010/84/EU of 21 July 2012 and 2012/26/EU of 25 October 2012 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use, have strengthened the regulatory framework for the surveillance of medicinal products in the European Union, making it more robust to ensure greater patient safety and better protection of public health.

The Pharmacovigilance Risk Assessment Committee (PRAC) has been established within the EMA, with representation from all Member States.
The PRAC deals with all aspects of risk management related to the use of medicinal products for human use, including the identification, evaluation, reduction and communication of the risk of adverse reactions. The PRAC issues recommendations to the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group (CMDh) on emerging pharmacovigilance issues and on risk management systems, and monitors their effectiveness.

The definition of an adverse reaction has changed and is now understood as 'a harmful and unintended effect resulting from the use of a medicine'. This definition includes adverse reactions due to medication errors, misuse, abuse, off-label use, overdose and occupational exposure. 

All adverse reaction reports are entered into the European Eudravigilance database, and are accessible to the public as aggregated data https://www.adrreports.eu/vet/it/index.html 

The pharmacovigilance legislation gives power to impose to marketing authorisation holders to conduct further studies on the safety and/or efficacy of the medicinal product, at the time of granting the marketing authorisation or subsequently, e.g. to provide reassurance on the absence of safety problems related to a specific adverse reaction or to study the use of the medicinal product in patients who were not included in clinical trials (post-authorisation safety study, PASS).

The legislation also contains provisions on specific procedures and/or issues relating to the activities that pharmaceutical companies are required to undertake in order to proactively identify not yet unknown risks associated with medicinal products.