Home » EMA Biosimilars Q&A Aims to Clarify Presubmission Issues, Review Timelines
EMA Biosimilars Q&A Aims to Clarify Presubmission Issues, Review Timelines
May 10, 2012
The European Medicines Agency (EMA) has published a question-and-answer guideline on marketing applications for biosimilars, providing advice on a number of presubmission issues, such as requesting an accelerated assessment, and giving detailed answers about review timing.
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