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."
Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.