The advice is given by EMA's Committee for Medicinal Products for Human Use (CHMP) on the basis of recommendations by the Scientific Advice Working Party (SAWP). This qualification process leads to a CHMP qualification opinion or CHMP qualification advice.
The CHMP can issue an opinion on the acceptability of a specific use of a method, such as the use of a novel methodology or an imaging method in the context of research and development.
The method can apply to non-clinical or to clinical studies, such as the use of a novel biomarker.
The opinion is based on the assessment of data submitted to the Agency.
Before finally adopting a qualification opinion, the CHMP makes its evaluation open for public consultation by the scientific community. This ensures that the CHMP shares information, as agreed with the applicant, and is open to scientific scrutiny and discussion.
EMA publishes all CHMP qualification opinions. For more information, see:
A question-and answer document with key points to consider for the successful qualification of digital technology-based methodologies intended to support the authorisation of medicines is available for applicants:
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. For more information, see:
An action plan is available outlining the steps that the European medicines regulatory network plans to take to future-proof its qualification process. It covers actions in 2024 and 2025.
It is in line with the strategic goals and recommendations of the European Medicines Agencies Network Strategy to 2025 and the EMA Regulatory Science Strategy to 2025.
EMA developed the action plan based on stakeholder input received at its multi-stakeholder workshop on qualification of novel methodologies from April 2023.
EMA published the action plan in September 2024.