EMA published a new guideline to be adopted in 2018 clarifying the type and level of information that should be included in the marketing authorization application (MAA) dossier with respect to the manufacturing process description.
[/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]