European Union (eu) action in the pharmaceutical sector has always had the dual objective of safeguarding public health by providing Europe with safe and effective medicines, while stimulating research, boosting innovation, and supporting the competitiveness of industry. To face major health, economic and scientific challenges, a series of measures have been adopted. Specific legal frameworks have been set up to improve patient safety by reducing the infiltration of counterfeit medicines into the supply chain, to increase the safety of medicines by modernising the pharmacovigilance system, as well as improving patient access by requiring high-quality health and medicine information. This article provides an overview of the new eu strategy aimed at increasing the safety and involvement of European patients, as well as the competitiveness of pharmaceutical industry in accordance with the principle of transparency. The analysis is carried out from a patients’ perspective addressing some paediatric specifications.