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.]
[/membership]
[membership level=”0,4″][The content continues for paid members only.]
Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership]