Drug Safety

Novartis and other pharmaceutical companies are obliged to establish and maintain comprehensive, worldwide networks to monitor safety of their products.

At Novartis the Clinical Safety and Epidemiology function – in collaboration with our local operating companies – is responsible for worldwide safety surveillance; the collection and reporting of safety data according to regulatory requirements of all Novartis investigational and marketed drugs; and for providing medical safety evaluations and epidemiological support for drug development activities.

Surveillance begins during initial stages of development of a new compound (or new formulation of an existing medicine) and is maintained throughout the lifetime of a product. The company’s drug-safety policy applies to all active pharmaceuticals undergoing evaluation or development in any clinical trial in any country – including products sold by third-party licensees, or co-marketed by Novartis and third parties.

Each local country organization in the Novartis group is responsible for overseeing the safety of pharmaceuticals it sells locally, for complying with local regulatory and legal obligations, and for communicating appropriate safety information to the Clinical Safety and Epidemiology staff at our central sites for onward processing. More than 400 associates are part of the drug-safety organization worldwide.

In yet another initiative, the Novartis Pharmaceuticals Division created a Product Stewardship Board responsible for proactively identifying, assessing and managing any possible product-related risk.

Generally, each marketed product is subject to a standard annual review by the Stewardship Board for the first five years following market authorization. Subsequent reviews take place every five years – in addition to any further unscheduled assessments deemed necessary.

The process aims to ensure appropriate product information and communications to doctors, patients and authorities. The Product Stewardship Board reports every quarter to the Pharmaceuticals Division Executive Committee. Both Sandoz and the Consumer Health Division have established similar product stewardship processes.