top of page

EMA Guidance: Qualification of Novel Methodologies for Drug Development, Guidance to Applicants

Recently the European Medicines Agency released an updated guidance on "Qualification of Novel Methodologies for Drug Development: Guidance to Applicants".

To facilitate this innovation, regulatory agencies such as the European Medicines Agency (EMA) play a crucial role by providing guidance to applicants. One such guidance, the "Qualification of Novel Methodologies for Drug Development: Guidance to Applicants (updated)," is a beacon for pharmaceutical companies seeking to harness novel approaches in their drug development processes.

The EMA Qualification is a process through which new methodologies or innovative tools can be evaluated and endorsed by the agency for use in drug development and regulatory decision-making. It's a recognition that novel methodologies have the potential to improve the efficiency, safety, or accuracy of drug development, ultimately benefiting both patients and the industry.

In this process, innovative drug development methods and tools will be examined, as well as novel methodologies developed by consortiums, networks, public-private partnerships, learned societies, and the pharmaceutical industry for specific purposes in pharmaceutical research and development.

A specialized group appointed by the CHMP, named the “qualification team,” led by two rapporteurs who are CHMP and/or SAWP members is in charge of the review of data and protocols, ensuring that efficient use is made of the resources available in the EMA experts’ network.

The procedure applicable to provide qualification advice is based on the existing Scientific Advice procedure adapted to host the activity of the Qualification team and to incorporate international collaboration. The operational sustainability of the process will require the levy of appropriate assessment.

The process is reviewed on a yearly basis to be adjusted to the workload and the needs of the parties involved. The preparatory discussion with the EMA is free of charge. Applications should be submitted via EMA's secure online IRIS platform.

Click this LINK to learn more about the procedures for the qualification of novel methodologies.


bottom of page