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POLICY BRIEF article

Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1470908

Identifying and Overcoming Challenges in the EMA's Qualification of Novel Methodologies: A Two-Year Review

Provisionally accepted
Ana Drmić Ana Drmić 1Riccardo Saccà Riccardo Saccà 2,3*Thorsten Vetter Thorsten Vetter 2Falk Ehmann Falk Ehmann 2
  • 1 European Directorate for the Quality of Medicines and HealthCare (EDQM), Strasbourg, Alsace, France
  • 2 European Medicines Agency, Amsterdam, Netherlands
  • 3 Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands, Netherlands

The final, formatted version of the article will be published soon.

    The EMA Qualification of Novel Methodologies (QoNM) procedure qualifies methods, technologies and methodologies within a well-defined context of use (CoU) in a pharma R&D context based on the evaluation of the presented scientific rationale and submitted data. This policy brief analyses QoNM submissions providing policy messages and recommendations to stakeholders on how to better prepare qualification applications in this regard. The recommendations include: 1. Grounding validation strategy using a current standard measure or a distribution technique 2. Accurately represent pertinent subgroups via accurate inclusion and exclusion criteria. 3. Establish a well-defined and specific CoU with clear descriptions of the use within a development program target population and disease stage. Lastly, it emphasizes role of the QoNM procedure in advancing medicine development methodologies within the EU.

    Keywords: Qualification of Novel Methodologies, Regulatory Science, European Medicines Agency, Context of use, biomarker qualification (Min.5-Max. 8)

    Received: 26 Jul 2024; Accepted: 28 Oct 2024.

    Copyright: © 2024 Drmić, Saccà, Vetter and Ehmann. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Riccardo Saccà, European Medicines Agency, Amsterdam, Netherlands

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.