Zdrowie i gospodarka · 19/07/2000

International Conference on Harmonisation; Draft Revised Guidance on Impurities in New Drug Products

The Food and Drug Administration (FDA) is publishing a draft revised guidance entitled "Q3B(R) Impurities in New Drug Products." The draft revised guidance, which updates a guidance on the same topic published in the Federal Register of May 19, 1997 (the 1997 guidance), was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft revised guidance clarifies the 1997 guidance, adds information, and provides consistency with more recently published ICH guidances. The draft revised guidance is intended to provide 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 draft revised guidance is a complement to the ICH guidance entitled "Q3A Impurities in new Drug Substances," which is being revised also.