2001 Volume 3 Issue 1 Pages 1-7
ICH Guideline “Specification: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances” (Q6A Guideline) reached consensus among USA, EU and Japan on November 1999. The objective of Q6A Guideline is to assist, to the extent possible, in the establishment of a single set of global specifications for new drug substances and new drug products. The most important features of this guideline are 1) new general concepts such as periodic/skip testing, in-process tests and parametric release, which have not been adopted in current drug approval - licensing system in Japan, are included, and 2) harmonization of test procedures among USP, EP and JP is strongly required. In order to support the implementation of this guideline in Japan, feasibility studies on the above three general concepts posed by Q6A guideline are now carrying out. In this speech, I would like to discuss the requirements for applying them in Japan based on the feasibility study reports of periodic/skip testing (1998) and in-process tests (1999). I'll also discuss the current status of pharmacopoeial harmonization on test procedures.