EMA-FDA QbD Pilot Program Led to Further Harmonization
By Zachary Brennan -
Published 19 April 2017
The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH).
Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration
Tags: QbD pilot, EMA-FDA joint program, quality by design