EN PL

GMP: Waiting for ICH Q3D (Step 4): Revision and Implementation of national Regulations delayed

10.07.2014
At the end of July 2013, the Draft Consensus Guideline \"Guideline for Elemental Impurities\" (step 2b document) was released and open for comments 6 months long. After considering all the comments received, the corresponding adaptation of the content and its publication should take place in June 2014. The delay in the acceptation and publication of the ICH Q3D guideline (step 4) also has consequences on the revision of some important national regulations in the three ICH regions.