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In the European Union the term pharmacovigilance is normally used to describe post-marketing or, more precisely, post-approval experience after the regulatory approval of drugs and their introduction to the market under defined conditions. The term describes activities used to gather information on the effects of medicinal products, with emphasis on those aspects which have not, or could not have been, detected in the pre-approval phase of the development of the product.

The term was first introduced in France more than two decades ago when authorities there set up and developed a national system to determine possible adverse reactions caused by medicinal products and to confirm or reject these reactions. In addition to this pharmacovigilance system, nationally agreed and implemented methods for collecting, reporting, and imputing suspected adverse drug reactions have been used.

When the term was included in the European regulations for medicines its meaning was extended to include all regulatory aspects of the evaluation of proprietary medicinal products resulting from, and relevant to, the description of the regulatory status and use of medicinal products after post-marketing authorisation of the product in the Union or in any of its member states.

Pharmacovigilance …