Regulatory Roundup: FDA and EMA Announce Joint Pilot Program

March 17, 2011
Pharmaceutical Technology Editors

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."