L'industriel du médicament face aux effets indésirables des médicaments

Then clinical trials are conducted, where tolerance profile knowledge is increased through the development with the detection of the most frequent adverse effects (between 1% and 1‰). At marketing authorization, because of the limited number and of the selectivity of patients enrolled in clinical trials, the drug safety profile is based on the more frequent adverse effects. In Europe, since November 2005, a new regulation - the Risk Management system - has been added to Pharmacovigilance. These are designed to better anticipate and even minimize important identified or potential risks or to better inform on populations not studied during the clinical trials. This concept is based on risk reduction throughout drug's life cycle with specific strategic actions in addition to the product information, in order to optimise the drug benefit/risk ratio. Pharmaceutical companies will therefore invest significantly in post-marketing, allowing proper and safety use of their products. As they played a major role in the clinical development few years ago, they could from now on, be recognised as the key player towards this new paradigm defined as the post-approval development.