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.
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 final adoption of 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.
The Agency publishes all CHMP qualification opinions.
Update: 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, the Agency 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 on-going and future investigations. The Agency publishes letters of support, if the sponsors agree.
EMA and the United States Food and Drug Administration (FDA) launched a joint
letter of intent
(LOI) in December 2014 to facilitate parallel submissions of applications for drug biomarker qualification or clinical outcome assessment.
The joint LOI allows the two agencies to share scientific perspectives and advice. The agencies are also able to provide the same response to submitters.
With the joint LOI, the agencies intend to reduce the time taken by applicants to prepare LOIs. However, applicants do not have to submit jointly to EMA and the FDA - they can send EMA or FDA-specific LOIs separately if they wish.
Some sections of the LOI are specific for EMA or the FDA. See the template for details.
Qualification of novel methodologies for drug development: guidance to applicants (PDF/169.54 KB)
First published: 22/01/2009
Last updated: 12/11/2014
EMEA/CHMP/SAWP/72894/2008 Rev. 3
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
Template letter of intent for request of qualification of novel methodologies to the Scientific Advice Working Party (DOC/191.5 KB)
First published: 18/09/2009
Last updated: 18/03/2020
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 2020 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/253.73 KB) (updated)
First published: 24/08/2018
Last updated: 08/07/2020
EMA/444946/2017 Rev. 2
Dates of 2019 Scientific Advice Working Party (SAWP) meetings and submission deadlines for scientific advice, protocol assistance, qualification of biomarkers and parallel consultation EMA/EUnetHTA requests (PDF/233.31 KB)
First published: 01/10/2019