Qualification of novel methodologies for medicine development (QoNM)

The European Medicines Agency (EMA) provides a voluntary procedure to qualify innovative methodologies that generate data to support regulatory decisions throughout the medicinal product lifecycle.

The qualification of novel methodologies (QoNM) is a voluntary EMA procedure that supports the development, evaluation and endorsement of innovative methodologies.

EMA assesses each methodology within a defined context of use. This specifies the role and setting in which the methodology is applied.

Methodologies submitted for EMA qualification should apply to multiple medicinal products and developers, within a defined context of use.

They should support evidence generation throughout the medicinal product lifecycle – from pre-authorisation to post-authorisation. They can refer to quality, non-clinical and clinical settings.

EMA’s Committee for Medicinal Products for Human Use (CHMP) confirms whether a methodology is acceptable. It does so via qualification opinions published on this website.

For more information, see:

• Scientific advice and protocol assistance

In this section

High-level information on CHMP's qualification advice

At-a-glance information to promote collaboration among methodology developers

Letters of support

Letters to encourage data-sharing and collaboration to support further development of promising methodologies

CHMP qualification opinions

Formal CHMP opinion on the acceptability of a methodology for evidence generation in a defined context of use

Types of qualification interactions

Different qualification interactions are available to methodology developers. Depending on the maturity of the methodology under development, these include:

• Informal scoping meeting – to confirm eligibility of the methodology and prepare the required documentation
• Qualification advice – to advise on preliminary data and qualification plans needed to support a future qualification opinion
• Qualification opinion – to assess whether the methodology is acceptable for a specific context of use, based on the available supporting data

Information on novel methodologies

EMA publishes on this website the following information related to the development of novel methodologies:

• High-level information on all qualification advice requests – high-level information on methodologies submitted to the CHMP for qualification advice
• Letters of support – summaries of promising methodology developments that received qualification advice, published with the agreement of the developer
• CHMP qualification opinions – formal CHMP confirmation that a novel methodology is acceptable for generating evidence to assess benefit-risk of medicinal products in specific contexts of use

How to submit a novel methodology for qualification

EMA makes available procedural guidance and templates to help medicine developers submit a request for CHMP to qualify a novel methodology.

This guidance describes the following:

• Scope of novel methodology qualification
• Request preparation
• Early interaction before request submission
• Procedure management
• Outputs
• Considerations for evidence generation
• Lifecycle management

Select the expandable panel below to find the guidance documents and templates. They include a 'questions and answers' document on the qualification of digital technology-based methodologies to support approval of medicinal products.

Guidance documents for applicants

Qualification of novel methodologies for medicinal product development: guidance to applicants

Reference Number: EMEA/CHMP/SAWP/72894/2008 Rev. 6

Essential considerations for successful qualification of novel methodologies

Reference Number: EMA/750178/2017

Submission of comments on draft qualification opinion

Questions and answers: Qualification of digital technology-based methodologies to support approval of medicinal products

Reference Number: EMA/219860/2020

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in October 2026.

See update history

13 October 2026

• Page revised and updated
• Information on the outcomes of the qualification of novel methodologies for medicine development moved to new pages
• New pages linked in 'In this section'