Regulatory agencies like the FDA and the European Medicines Agency (EMA) require thorough evaluation of enantiomers in new drug applications. They emphasize the need for enantioselective preclinical and clinical studies to determine the pharmacological and toxicological profiles of each enantiomer. This is to ensure that the marketed product is both effective and safe for human use. Additionally, guidelines have been established for the development and approval of single-enantiomer drugs, which can offer advantages over racemic mixtures.
