New ICH Q4B Annexes

Under the roof of ICH, the Pharmacopoeial Discussion Group and the ICH Q4B Working Group have been dealing for years with the harmonisation of the requirements laid down in the pharmacopoeias of the three ICH regions. The two groups cooperate intensively.

The Pharmacopoeial Discussion Group was founded in 1990 und comprises representatives from EDQM, MHLW (Japan) and the USP. Its goal is to develop harmonised monographs (for excipients) and for the general chapters of the pharmacopoeia as e.g. for special test procedures. By now the group has progressed quite a bit, and there is a whole series of harmonised chapters and monographs.

The ICH Q4B Expert Working Group (EWG) was established in November 2003 by ICH and originally aimed at evaluating all test methods defined in the ICH Guideline Q6A (Specifications) and whether individual methods are compatible and accepted in the three ICH regions. Results are then published in method specific annexes in various steps, similar to the ICH procedure. The basic proceeding is described in the ICH Guideline Q4B - Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (step 4 from 1 November 2007).

In this document the term <interchangeable> is defined as follows: “Where such status is indicated, any of the official texts from JP, EP, or USP can be substituted one for the other (appropriately referenced) in the ICH regions for purposes of the pharmaceutical registration/approval process.” The complete document is available at

In June 2008 the ICH issued three ICH Q4B Annexes regarding microbiological topics.

In addition the Q4B Annex 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapters (Step 2 from 5 June 2008) was issued. Concluding the Q4B Expert Working Group recommends under the title “Analytic Procedures” that for tablets and capsules the official text of the pharmacopoeias

  • Ph.Eur. 2.9.1 Disintegration of Tablets and Capsules
  • JP 6.09 Disintegration Test
  • USP <701> Disintegration

can be used in the ICH regions interchangeably. In this connection, acceptance criteria were not discussed. It is not clear what constraints possibly result from item 4 (‚Considerations for Implementation’) which, then again, emphasise the perspectives of the individual regions.

This document can be found at

Dr Günter Brendelberger
On behalf of the European Compliance Academy (ECA)


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