ABSTRACT
The Japanese Ministry of Health and Welfare (MHW) communicated a new guideline for stability testing in April 1994 in response to the endorsement of the parent guideline, Stability Testing of New Drug Substances and Products by the International Conference on Harmonization (ICH) in October 1993. The Japanese guideline is sometimes mistakenly assumed to impose additional requirements in comparison to the ICH Guideline. The Guideline for the Photostability Testing of New Drug Substances and Products endorsed by the ICH in November 1996 was translated into Japanese and communicated in May 1997. Since this is the first guideline specific to photostability in Japan, the content of the ICH version was translated literally. When the ICH Harmonized Guideline was published in April 1994, the MHW began to prepare the guideline for bracketing and matrixing. A draft of the guideline has already been prepared in conjunction with the Japanese pharmaceutical industry.
