Draft ICH Q11 Q&A Guidance Would Clarify Starting Materials Selection
ICH regulatory members have agreed to request comment on draft Q11 Q&A guidance that is meant to clear up ambiguities on starting materials selection that have fueled debate between industry and regulators for years. The guidance also clarifies the difference between custom-manufactured and commercially available chemicals.
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A new Q&A document finalized by the International Council for Harmonisation aims to clarify and harmonize the information that companies should include in their marketing applications on the selection of starting materials for manufacturing drug substances.
There will be no easy answers on starting materials for drug substance manufacture, an ICH working group is finding. Draft guidance that could come later this year will explain the differences between chemicals that are custom-made and those that are commercially available and is expected to outline in more detail the information needed in submissions for starting materials.
The European Medicines Agency is attempting to clarify what information drug companies should include in their marketing authorization dossiers to justify the selection of starting materials in light of 2012 International Conference on Harmonisation guideline Q11 that covers this topic.