EMA and FDA agree how drug firms should include Q8, Q9 and Q10 QbD concepts in applications

The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.

http://www.in-pharmatechnologist.com/Regulatory-Safety/EMA-and-FDA-aligned-on-how-pharmas-should-include-QbD-in-applications