Qualification of novel methodologies for medicine development
The CHMP can issue advice on protocols and methods that are intended to develop a novel method with the aim of moving towards qualification.
The advice is based on the evaluation of the scientific rationale and on the preliminary data submitted to the Agency.
Based on qualification advice, EMA may propose a letter of support as an option, when the novel methodology under evaluation cannot yet be qualified but is shown to be promising based on preliminary data.
Letters of support aim to encourage data-sharing and to facilitate studies aimed at eventual qualification for the novel methodology under evaluation.
These letters include a high-level summary of the novel methodology, context of use, available data and ongoing and future investigations. The Agency publishes these letters of support if the sponsors agree.
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