This video explains the Qualification of Novel Methodologies (QoNM) procedure within the European Medicines Agency (EMA) framework. It highlights the importance of qualification as a tool to integrate scientific and technological advancements into medicine development and regulatory decision-making. It explains engagement pathways, including the Innovation Task Force (ITF) for early discussions and scientific advice for product-specific methodology validation. The qualification process is voluntary, risk-based, and involves rigorous assessment to ensure methodologies are broadly applicable and meet regulatory standards. It also emphasizes the need for early engagement, transparent data sharing, and adherence to regulatory guidelines to accelerate medicine development and approval.
EMA’s Qualification of Novel Methodologies procedure
The Innovation Management Toolbox was originally developed through funding from the EJP RD project, which received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 825575.
The continued development and maintenance of the Toolbox are now supported by the ERDERA partnership, funded under the European Union’s Horizon Europe Research & Innovation programme, grant agreement No. 101156595.