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.
On 29 February 2012 guidelines and Q&As were revised; for details see here.
document date 2006-12-07 | last update 2019-03-14