Patient safety is at the heart of drug development and licensing processes. But the duty of care does not stop at launch. Manufacturers must satisfy strict regulatory demands throughout a product’s lifecycle, including re-labeling.
Regulatory bodies all over the world continue to address issues that became apparent in the financial crisis. The beginning of the New Year is a good point in time to take stock of the regulations that has entered into force on 1 January 2015, and of regulations in discussion during 2015.