Qualification of novel methodologies for medicine development
Qualification of novel methodologies for medicine development
The EMA's Committee for Medicinal Products for Human Use (CHMP) gives opinions on the qualification of novel methodologies for medicine development based on recommendations that EMA's Scientific Advice Working Party provides.
This qualification process leads to a CHMP qualification opinion or advice.
For more information on EMA's scientific advice and protocol assistance, see:
Also on this topic
- Opinions and letters of support on the qualification of novel methodologies for medicine development
CHMP qualification opinions
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:
- Opinions and letters of support on the qualification of novel methodologies for medicine development
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:
Questions and answers: Qualification of digital technology-based methodologies to support approval of medicinal products
Reference Number:
EMA/219860/2020
English (EN) (284.18 KB - PDF)
First published:
27/05/2020
Last updated:
04/06/2020
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CHMP qualification advice and letters of support
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:
- Opinions and letters of support on the qualification of novel methodologies for medicine development
Action plan for future-proofing qualification of novel methodologies
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.
Future-proofing Qualification of Novel Methodologies (QoNM) - Action plan
English (EN) (666.07 KB - PDF)
First published:
04/09/2024
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Guidance for applicants
Qualification of novel methodologies for medicinal product development: guidance to applicants
Reference Number:
EMEA/CHMP/SAWP/72894/2008 Rev. 6
English (EN) (623.3 KB - PDF)
First published:
22/01/2009
Last updated:
07/07/2026
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Overview of comments received on draft guidance document on qualification of biomarkers
Reference Number:
EMEA/380215/2008
English (EN) (94.69 KB - PDF)
First published:
22/01/2009
Last updated:
22/01/2009
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Essential considerations for successful qualification of novel methodologies
Reference Number:
EMA/750178/2017
English (EN) (82.65 KB - PDF)
First published:
06/12/2017
Last updated:
06/12/2017
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Questions and answers: Qualification of digital technology-based methodologies to support approval of medicinal products
Reference Number:
EMA/219860/2020
English (EN) (284.18 KB - PDF)
First published:
27/05/2020
Last updated:
04/06/2020
View
Submission of comments on draft qualification opinion
English (EN) (150.35 KB - DOCX)
First published:
28/02/2024
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Related content
- Opinions and letters of support on the qualification of novel methodologies for medicine development
Video: Online training
The below video explains:
- How to register for access to IRIS
- What research product identifiers (RPI) are
- How EMA uses research product identifiers
EMA organised this online training on 24 September 2020.
Topics
Summary
The European Medicines Agency (EMA) offers scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals.