International Conference on Harmonisation; evaluation of stability data; availability. Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q1E Evaluation of Stability Data." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance is a supplement to an ICH guidance entitled "Q1A(R2) Stability Testing of New Drug Substances and Products," which was revised from Q1A(R) and published in the Federal Register of November 21, 2003 (68 FR 65717). It is intended to provide guidance on how to use stability data, generated in accordance with the principles outlined in Q1A(R2), to propose a retest period for the drug substance and a shelf life for the drug product.