EMA has published a reflection paper regarding the information to be submitted in marketing authorization dossiers to justify the selection of starting materials. The document reproduces extracts from section 5 of ICH Q11 verbatim and provides subsequent commentary on EU expectations in the form of explanatory notes. [For more on discussions around starting materials in the EU and internationally, see IPQ Jan. 30, 2016, July 10, 2015, and Sept. 22, 2013.]
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