THE GUIDE FOR EVALUATING MICROBIOLOGICAL/BIOLOGICAL ANALYSES HAS BEEN UPDATED!

Content addition date : 27-02-2026

The second paragraph of Article 3 in the Guide for Evaluating Microbiological/Biological Analyses has been revised.

The provision that "For products other than product types 14 and 21, whose long-term stability tests are ongoing/repeated or for which new license applications are submitted, efficacy analyses will be repeated after the long-term stability analysis. For products whose long-term stability analyses were completed before the publication date of this guide, repeat efficacy testing will not be required." 

Click here to access the updated guide.