The Maintenance Procedure is currently applicable for changes to the Q3C, Q3D and M7, Q4B (Annexes) and S5 (Annexes 1 & 2) Guidelines and M2 Recommendations. In each case the procedure is used when there is new information to be added or the scientific/technical content is out-of-date or no longer valid.
More information on the current ICH Maintenance Procedures can be found in the Standard Operating Procedures (SOP) for Working Groups available for download on the "Articles and Procedures" page.
Maintenance Procedure for Q3C Guideline on Impurities: Residual Solvents and Q3D Guideline for Elemental Impurities
The Maintenance Procedure for Q3C/Q3D is followed when there is a proposal of a Permitted Daily Exposure (PDE) for a new solvent/elemental impurity or a revised PDE for an already classified solvent/elemental impurity. The procedure is similar to the Formal ICH Procedure in that it follows the 5 ICH steps.
Maintenance Procedure for M7 Guideline for the Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
The Maintenance Procedure for M7 is followed when there is a proposal of a Acceptale Intakes (AIs) or PDE for a new DNA reactive (mutagenic) impurity or a revised AIs/PDE for an already classified DNA reactive (mutagenic) impurity. The procedure is similar to the Formal ICH Procedure in that it follows the 5 ICH steps.
Maintenance Procedure for Annexes of the Q4B Guideline Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
In November 2018, ICH and the Pharmacopoeial Discussion Group (PDG) agreed to collaborate in the maintenance of the current ICH Q4B Annexes. The Maintenance Procedure for Q4B Annexes is triggered by the PDG's sign-off of a revised text which is the subject of an existing Q4B Annex.
Maintenance Procedure for Annexes 1 and 2 of the S5 Guideline on Detection of Toxicity to Reproduction and Development for Human Pharmaceuticals
The Maintenance Procedure for S5 is followed when there is a proposal of a revision to either Annex 1 concerning the recognition and implementation of modifications of in vivo studies resulting from advances in understanding of strengths and weaknesses of these studies in predicting human reproductive risk associated with exposure to pharmaceuticals, and or Annex 2 concerning the reference compound list (integration of new data or compounds), the qualification of alternative assays (improvement of approaches to qualify an alternative assay using the reference compounds list based on gained experience) and/or scenarios of use (inclusion of new scenarios and harmonization of the use of scenarios across regions). The procedure is similar to the Formal ICH Procedure in that it follows the 5 ICH steps.
Maintenance Procedure for M2 Recommendations
Due to the Information Technology (IT) nature of the M2 EWG's work on Electronic Standards for the Transfer of Regulatory Information (ESTRI), some of their activities result in Recommendations. These Recommendations do not undergo the formal ICH step process, so as to allow for flexible change as both science, and technologies evolve. They are agreed in the EWG, signed by all Members of the EWG, and are approved by the ICH Assembly.
Each new version of the M2 Recommendations is designated by a different version number.