New legislation in the US, Europe and other countries has made demonstration of drug safety a key priority for drug approval and continued marketing. To thrive in this new era, the pharmaceutical industry needs to incorporate new strategies and tactics.
Pharmaceutical companies will need to change their drug development efforts to plan for higher thresholds of approval related to the relative benefits and risks of pharmaceuticals. This involves the development of a more comprehensive process of assessing potential risks in relation to likely benefits, alternative therapies and the disease being treated to drive the development of the product profile.
This process also makes it easier to anticipate and develop post-marketing surveillance and risk minimisation activities that may be needed in the post-marketing period. Both of these activities are increasingly required by regulatory authorities throughout the world to ensure that the benefit to risk profile remains positive for patients using the medication.
These changes to both the drug development and commercialization approach will help companies to improve management of product risks and ensure commercial success.