Regulatory Roundup: FDA and EMA Announce Joint Pilot Program - Pharmaceutical Technology

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Regulatory Roundup: FDA and EMA Announce Joint Pilot Program

ePT--the Electronic Newsletter of Pharmaceutical Technology

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."

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