On 24 November 2006 Japan’s NIHS published revisions to four BE Guidelines and corresponding Questions & Answers Documents.
Revised Guidelines and corresponding Q&A Documents are:
A new ‘Guideline for BE Studies of Adding Dosage Form for Topical Use’ was also published.
The ‘Guideline on Oral Prolonged Release Dosage Forms’ (Mar 1988) was not revised.
As of today (04 Jan 2011) Q&A documents of #1–#3 are only published in Japanese, as well as the guidelines on topicals. If you don’t know Japanese, check the English site for eventual Translations.
document date 2006-12-07 | last update 2011-07-26