The safety of a medicinal product, as well as its efficacy, is continuously monitored by regulatory agencies even after it has been placed on the market. This monitoring occurs through routine clinical use and post-authorisation studies. Any new evidence may lead to changes in the safety profile of a medicine. In such cases, regulatory agencies intervene to revise the conditions and modalities of use, providing healthcare professionals - and, through them, patients - with timely updates and guidance to ensure the safe use of medicines.

These communications - called Important Safety Information (ISI) or Direct Healthcare Professional Communications (DHPC) - are a key tool for protecting public health, as they ensure that healthcare professionals are promptly informed about relevant updates concerning the safety and use of medicines.

However, experience over time has shown that ISIs, when disseminated through pharmaceutical companies, are not always immediately recognised as official safety communications issued by AIFA. This may lead to their importance being underestimated or to less careful reading, despite their critical role in safeguarding public health.

For this reason, and in line with European best practices, AIFA has developed an official pictogram designed to make ISIs immediately recognisable to healthcare professionals.

“The safety of medicines - says AIFA’s President Robert Nisticò - depends not only on the robustness of regulatory assessments, but also on the ability to make safety information immediately accessible and recognisable to healthcare professionals in their daily practice. In this context, the introduction of a pictogram to identify Important Safety Information responds to the need to strengthen its visibility and reflects AIFA’s ongoing commitment to protecting public health.”

The initiative is intended to enable doctors and pharmacists to recognise such communications at a glance, thereby promoting a more informed and attentive approach to regulatory information.
The new symbol features a colour scheme combining institutional blue and red, along with clear visual elements - specifically, a magnifying glass with an exclamation mark -designed to immediately convey the concepts of attention and vigilance.

Starting with upcoming communications, all ISI issued by AIFA will include this pictogram, which will appear:

• •    on the outer envelope, in the case of paper-based mailings;
• •    in the body of the email, for electronically distributed ISI;
• •    within the ISI document itself, as a distinctive visual identifier.

AIFA assigns strategic importance to this initiative as part of its broader efforts to strengthen the pharmacovigilance system.

“The growing volume of information on health and medicines - states AIFA’s Technical-Scientific Director Pierluigi Russo - makes it essential to adopt tools that facilitate the identification of relevant communications. The pictogram has been developed to support healthcare professionals in the proper use of these communications, which require careful attention due to their direct implications for patient safety.”

Finally, the Agency notes that all ISIs are systematically published in a dedicated section of the AIFA website.

Published on: 26 May 2026