Abstract
The spatial organization of ligands around a chiral center in a drug molecule can have profound effects on the pharmacodynamic, pharmacokinetic, and toxicologic properties of the single enantiomers as compared to each other and to the racemic drug. Regulatory agencies have, therefore, started to consider the various problems arising from the development and the registration of single enantiomers as drugs.
The Swiss Intercantonal Office for the Control of Medicines (IOCM) has tried to approach these issues in a rather pragmatic way. It has published a short notice in which its position with regard to these new developments is stated. In this notice, the IOCM declared how it intends to adapt and interpret the formal requirements for the registration of a “normal” drug to the special considerations holding for enantiomerically pure drugs, as well as for racemic drugs. Such adaptations are necessary for all parts of the registration documentation, that is, for the analytical, the preclinical, and the clinical parts.
The position of the IOCM concerning the registration procedures for chiral drugs can be summarized in a few words: The application for registration, whether for a racemate or for a pure enantiomer, has to be based on sound scientific reasoning; the IOCM, on the other hand, strives for good science and common sense in its decisions regarding chiral substances.
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