[Excipients: regulatory aspects]

Strictly speaking, there are no specific regulations on excipients but their use in the preparation of medicines clearly makes them essential to the quality, efficacy and safety of these medicines; consequently, the regulatory framework for excipients derives from the regulations concerning medicines. The conditions for the use of excipients in Europe are defined in the European regulations, either within the framework of the European Union through Community directives and guidelines prepared by the European Agency for the Evaluation of Medicinal Products, or within the framework of the Council of Europe and the European Pharmacopoeia Convention through standards prescribed in the European Pharmacopoeia itself; the two types of regulations complement each other. After a brief overview of the general regulations on medicines, during which the key points relevant to excipients will be highlighted, we will successively discuss the regulations that bear on the conditions of use of excipients in medicines.