Regulatory Roundup: FDA and EMA Announce Joint Pilot Program

March 17, 2011

FDA and EMA Announce Joint Pilot Program

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