FDA and EMA announced on Mar. 16, 2011, that they would carry out a joint
pilot program for parallel assessment of quality-by-design-based new drug
applications. The pilot applies to applications submitted to both agencies.
According to a press release, the "parallel evaluation within this voluntary
pilot program means that reviewers from both agencies will separately assess
the quality/chemistry, manufacturing and control (CMC) section of the new
drug applications (NDAs) submitted to the FDA and marketing authorization
applications (MAAs) submitted to the EMA."