Zdrowie i gospodarka · 17/12/2009

FDA Releases Draft Guidance on Harmonization of Pharmacopoeial Texts for Use in ICH Regions

The FDA has made available a draft guidance document that outlines the results of the ICH Q4B evaluation of the Analytical Sieving General Chapter harmonized text from the US, European, and Japanese pharmacopoeias, aiming to recognize the interchangeability between local regional pharmacopoeias and promote a common testing strategy across ICH regulatory regions.