Regulatory aspects of stability testing in Europe.

The stability data requirements for human pharmaceuticals in the European Community (EC) are based on a series of Directive and Regulation requirements and on a series of advisory guidelines that have been developed and adopted through the International Conference on Harmonization (ICH) procedures or, where there is no relevant ICH project, through the Committee for Proprietary Medicinal Products (CPMP). There are relevant requirements that cover new drugs and finished products containing them and also for existing active ingredients and products containing them. The sources of the relevant information and the data requirements are discussed and summarized.