ABSTRACT
The preamble in the International Conference on Harmonisation (ICH) Tripartite Stability Guideline is very specific in stating that it sets out the requirements for the registration application within the European Union, Japan and United States and seek to cover the testing that may be required for export to or registration in the rest of the world. The basic tenet was that all ICH guidelines be based on good scientific principles, on the current practices and positions of historical perspectives. Since the release of both the ICH and World Health Organization guidelines, several regulatory authorities, in particular those associated with countries that experience hot and humid climatic conditions, have revised or restated the local requirements. However, there is no scientific reason why the ICH protocol could not be used as a basis for a single, unified protocol that would be acceptable for global purposes.
