Zdrowie i gospodarka · 17/02/2009

FDA Releases Draft Guidance on Harmonizing Pharmacopoeial Texts for Use in ICH Regions

The Food and Drug Administration (FDA) has made available a draft guidance document that outlines the results of the International Conference on Harmonisation's (ICH) Q4B evaluation of the Uniformity of Dosage Units General Chapter harmonized text from the United States, European, and Japanese pharmacopoeias, with the aim of recognizing the interchangeability between local regional pharmacopoeias and promoting a common testing strategy across ICH regulatory regions.