The European Medicines Agency Experience with Biomarker Qualification
Since the launch of the qualification process in 2009, the CHMP reviewed/is reviewing 48 requests for qualification advice or opinion (as of Sept 2013) related to biomarkers (BM) or other novel drug development tools (e.g. patient reported outcome measures, modeling, and statistical methods). The qualification opinions are available on the EMA website (Qualification of novel methodologies for medicine development, http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp&mid=WC0b01ac0580022bb0#section2, 2013). Also there is a trend of increasing numbers of qualification requests to CHMP, indicative of the pace that targeted drug development and personalized medicine is gaining and the need to bring the new tools from research to drug development and clinical use. This chapter will focus on the regulatory experience gained so far from the CHMP qualification procedure. Basic qualification principles will be presented. Through qualification examples, we will elaborate on common grounds and divergences between the different stakeholders.
Key wordsQualification Biomarkers Regulatory EMA
The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties.
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