US
FDA and the EMA are publishing a series of joint question-and-answer documents
that outline the conclusions of their first parallel assessment of
quality-by-design (QbD) elements of a marketing authorization application. One
of the projected outcomes of this pilot was to share key findings with the
public.
FDA
and EMA will publish additional question-and-answer documents on other QbD-related
topics as the pilot program continues and more parallel assessments are
conducted. Both agencies found the parallel assessment useful and reached
agreement on a wide range of QbD aspects. At the request of the applicant,
experts from the Japanese Pharmaceuticals Medical Devices Agency also
participated as observers in this first parallel assessment.
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