The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted the first application for parallel review under the two agencies’ joint pilot program to evaluate marketing authorization applications involving quality by design (QbD). The pilot was announced in March in an effort to maximize efficiencies among EMA, FDA and drug sponsors. The first application comes from Pfizer. According to an EMA statement, the two regulatory agencies “will communicate with and consult each other regularly during the evaluation process, resulting, if possible, in a common list of questions to the applicant and harmonised evaluation of the applicant's responses.”
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