Perspectives of Enantioselective Analyses

In 1990, Brown [1] described the present situation as follows: “Lack of appreciation (but not of knowledge) of the facts that stereoisomers are different compounds and that enantiomers often exert different biological effects has been one factor leading to failure to recognise the significance of chirality in assuring safety, quality and efficacy for medicinal products”. Public concern about chiral environmental pollutants can be stated at least since the “Thalidomide/Contergan® case” (see Sect. 4.1). However, adequate regulatory steps have only been taken so far for chiral drugs, while the application of chiral pesticides still needs corresponding regulations both at national and international levels. This lack of regulation seems to be world-wide and results in case-by-case judgments. A survey of the legal implications of chirality is given in several review papers and monographs [1–5]. With regard to the registration of chiral drugs, Witte et al. attempted an overview of the situation in three of the world’s most important pharmaceutical areas [4], the most important issues of which are as dealt with in the following sections.