"Significant Progress" At Pre-ICH IV Meeting

This month, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use's Steering Committee and its Expert Working Groups made "further significant progress" towards initial targets for harmonization in anticipation of ICH IV next July. The meeting, in London, was hosted by the European Agency for the Evaluation of Medicinal Products and the European Federation of Pharmaceutical Industry Associations.

The Committee adopted finalized tripartite harmonized ICH guidelines on: Periodic Safety Update Reports (Code E2C); Photostability Testing (Q1B); Stability Testing for New Formulations (Q1C); Impurities in Dosage Forms (Q3B); and Validation of Analytical Methods: Methodology (Q3B). Implementation is recommended.

Draft texts on which scientific consensus has been reached were released for formal regulatory consultation on: General Considerations for Clinical Trials (Code E8); Safety Studies for Biotechnological Products (S6); a draft Addendum to the Guideline on Dose Selection for Carcinogenicity Studies (S1C rev); Genotoxicity: Standard Battery Tests (CS2B); and Impurities: Residual Solvents (Q3B).