Additional Role of EMA

EMA focuses on medicinal products (medicines) regulation. EMA's remit as regards DHTs is limited to the specific use of a methodology in the development, use or monitoring of medicinal products pre- or post- authorisation, taking into account the expected role of such technologies. In other words, if a digital technology is used in the context of medicines development, evaluation or monitoring, and is expected to impact, even potentially, on the benefit-risk assessment of a Marketing Authorisation Application (MAA), then relevant aspects of the technology will be discussed at the time of MAA evaluation.

In order to be acceptable for a specific use of a method, such as the use of a novel methodology in the context of research and development this new methodology must undergo a qualification procedure by EMA1. EMA has published a question-and answer document [1] with key points to consider for the qualification of digital technology-based methodologies intended to support the authorisation of medicines.

Examples given by EMA:

  • Sensors (e.g. ingestibles, implantables),
  • Mobile health (mHealth) tools (e.g. wearable device to collect data from clinical studies, aspects on how such data support the benefit-risk assessment (e.g. endpoint outcomes, reliability, accuracy, sensitivity to change, clinical and technical validity aspects, compliance, clinical relevance of data collected, data reflected in the product information, remote patient monitoring),
  • Tele-healthcare in clinical trials (e.g. video consultations),
  • Health data analytics (e.g. data processing systems that support bioinformatics modelling)
  • Digital record systems (e.g. digital applications, also referred to as “apps”)
  • Digital biomarkers
  • Eelectronic clinical outcome assessment (COA) for use in a clinical trial to support the development of a medicinal product in a given therapeutic area (Content validity, Construct validity, Reliability, Sensitivity to change)

Content of a request for qualification should include for example:

  • Evidence to support the adequacy and transparency of performance characteristics.
  • The (added) benefit of using digital measures over existing methods.
  • Clinical usefulness of the digital technology (usability of the technology plus its utility) in terms of the benefits and drawbacks of the use.
  • Specification and justification of impact on diagnostic thinking, patient management and clinical outcome.

Must not include;

  • Requirements on how to meet the conformity assessment of a medical device software or for medical devices used to administer medicinal products, if applicable.
  • The aspects related to the technical design and in-use safety and performance, which are not expected to impact benefit-risk assessment of medicinal product.
  • Aspects beyond the medicines’ legal and regulatory framework.


Note 1: The EMA qualification of novel methodologies is a voluntary scientific pathway to establish the regulatory acceptability of a specific use of a methodology for the development of medicinal products. This qualification process leads to a Committee for Medicinal Products for Human Use (CHMP) qualification opinion or CHMP qualification advice on the acceptability of the innovative method concerned for a specific intended use, published by EMA together with letters of support for novel methodologies that have been shown to be promising in the context of R&D in pharmaceuticals.


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