Disagreement over how to justify starting materials selection prompts EMA action
This article was originally published in SRA
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.
You may also be interested in...
EMA has issued a revised reflection paper that clarifies where in the CTD information on starting materials should go and says that manufacturers can submit certificates of suitability for justifying their use of starting materials under ICH Q11.
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.
The European Directorate for the Quality of Medicines & HealthCare is proceeding carefully to find the right balance between serving the diverse requirements of various stakeholders that make use of its ‘certificates of suitability.’