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Regulatory Implications of Excipient Changes in Medicinal Products

Health authorities increasingly recognize the role excipients play as essential constituents of medicinal products. Pharmaceutical excipients contribute unique functionalities to formulations, thereby largely determining the drug product's quality and influencing its safety and efficacy. Changes and variations of excipients in licensed products are, therefore, placed under strict regulatory control. In this paper three levels of excipient change with potentially increasing impact on the performance of the pharmaceutical formulation are distinguished. The regulatory implications further depend on the function of the particular excipient in its specific formulation. The first change level relates to the quality variations that may result when changing excipient manufacturer. Such variations are generally larger and of higher regulatory impact than the usual batch-to-batch quality variations occurring for excipients obtained from one single manufacturer. However, when an excipient manufacturer changes its manufacturing site, its equipment, or its specifications the change in excipient quality may also have significant influence on its functionality in the drug formulation. The second change level relates to a change of excipient grade or in excipient concentration. The third change level relates to substitution of an excipient by another excipient of the same or similar functionality.