Qualification of novel methodologies for medicine development
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.
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.
Applicants should use EMA's secure online IRIS platform to apply for qualification from EMA:
The IRIS platform provides a single space for applicants and EMA to submit requests, communicate, share information and deliver documents concerning a qualification procedure.
Applicants first need to complete the registration steps set out in the Quick interactive guide to IRIS registration process before using IRIS to apply for qualification.
The IRIS platform homepage also provides guidance on registering and using IRIS to make regulatory submissions.
Applicants need to upload a complete draft dossier in IRIS at the time of application.
For regulatory guidance on applying for qualification, including the dossier contents, see Guidance for applicants seeking qualification of novel methodologies.
For information on submission deadlines, see Scientific advice and protocol assistance: Regulatory and procedural guidance.
EMA uses research product identifiers (RPIs) to track medicines through pre-authorisation procedures.
The RPI replaces the previously-used unique product identifiers (UPIs). EMA has converted previously assigned UPIs into RPIs.
Companies and individuals that approach EMA for the first time with a new methodology will need to request a new RPI via email to email@example.com.
Applicants need to use this RPI every time they contact the Agency for any matter related to this specific methodology.
Assigning RPIs helps to make EMA's processes more efficient. It also helps to create a unique platform for all pre-authorisation activities.
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.
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.
Qualification of novel methodologies for drug development: guidance to applicants (PDF/331.56 KB)
First published: 22/01/2009
Last updated: 19/10/2020
EMEA/CHMP/SAWP/72894/2008 Rev. 4
Overview of comments received on draft guidance document on qualification of biomarkers (PDF/94.69 KB)
First published: 22/01/2009
Last updated: 22/01/2009
Essential considerations for successful qualification of novel methodologies (PDF/82.65 KB)
First published: 06/12/2017
Last updated: 06/12/2017
Questions and answers: Qualification of digital technology-based methodologies to support approval of medicinal products (PDF/284.18 KB)
First published: 27/05/2020
Last updated: 04/06/2020
Dates of 2021 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests (PDF/224.37 KB)
First published: 22/06/2020
Last updated: 26/05/2021