Regulatory submissions

Any Novartis submission to regulatory authorities for a new chemical entity or new indication for an existing drug includes a core safety risk management plan. The plan summarizes safety information already known at the time of application and outlines our commitment to further monitor and study the risks of the drug, as well as specific efforts to minimize any risks to patients.

As a matter of policy, Novartis submits these plans whether or not governments or regulatory bodies require them.

By focusing on risk minimization - measures such as product labeling, special packaging, educational programs or, where necessary, restricted use - we help ensure that physicians prescribe and patients use our drugs in the safest manner possible.