International Conference on Harmonisation; Guideline on Impurities in New Drug Products; Availability

摘要

The Food and Drug Administration (FDA) is publishing a guideline entitled ``Impurities in New Drug Products.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline provides guidance for registration or marketing applications on the content and qualification of impurities in new drug products produced from chemically synthesized new drug substances not previously registered in a region or member State. The guideline is an annex to the ICH guideline entitled ``Impurities in New Drug Substances.''