Patient safety

To make a difference for the health and well-being of patients, Novartis medicines must have the complete confidence of those who prescribe and use them. As a corporate citizen, we are committed to this goal.

Patients and healthcare providers must know that Novartis, in addition to meeting regulatory requirements for product safety and efficacy, does everything it can to communicate any potential concerns based on clinical trials and other research. Often that communication appears directly on the medicine's label or in its package insert, describing any undesired effects and other risks and providing directions on how to avoid potential problems.

Ensuring patient safety does not end with the approval of a product. Once a medicine is on the market, we continue to assess risks or safety signals that may emerge. We continue to find new and better ways to identify problems and communicate them as transparently as possible.

Novartis discloses data from our clinical trials no matter what the outcome. We are organized to continually assess safety concerns throughout the development of our products and their life cycle on the market.

We conduct sophisticated pharmacovigilance programs to identify new adverse events, address them and communicate them quickly to regulatory agencies such as the US Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA), as well as to healthcare professionals and patients. And we do everything we can to protect patients from counterfeit products - a growing concern around the world.

Responsible corporate citizenship is about open communication, going beyond the letter of the law, and putting the patient front and center in everything. There is nothing more important we can do than to focus on the safety of our products and those who use them.