EMA Clarifies That CEPs Can Be Used To Justify Starting Materials Under ICH Q11
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.
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The pharmaceutical industry and regulators are wrangling yet again over what constitutes a starting material. While some are anticipating that an upcoming ICH question-and-answer document will clarify this question, others are suggesting that now may be a good time to resurrect some concepts from an earlier FDA guidance on starting materials that has since been withdrawn.
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.
API manufacturers in the U.S. and the EU say the ICH Q11 guidance lacks specific direction on when chemicals become starting materials, and as a result there are differing interpretations on designation among regulators. A member of ICH Q11 group advised industry to focus on supply chain, not steps.