Opinions and letters of support on the qualification of novel methodologies for medicine development

The EMA’s Committee for Medicinal Products for Human Use (CHMP) issues opinions on the qualification of novel methodologies for medicine development, acting on recommendations from the EMA Scientific Advice Working Party. The CHMP may provide either a qualification opinion or qualification advice on the acceptability of a specific novel method (for example a biomarker, imaging modality or digital tool) within a defined context of use in non‑clinical or clinical studies.

These opinions are based on assessment of data submitted to EMA and focus on whether the methodology is fit for its proposed role in drug development rather than on the approval of a specific medicinal product.

EMA CHMP qualification opinions and qualification advice can be very valuable when investigators are designing a clinical trial protocol because they provide regulatory confidence that a novel methodology is appropriate for a specific purpose in drug development. They do not replace protocol development or regulatory approval of the trial, but they can strengthen the scientific and regulatory rationale for key design decisions. In the protocol, investigators can reference a relevant CHMP qualification to:

• justify the selection of biomarkers, imaging techniques, or digital tools
• explain how these methods align with current regulatory expectations
• support the scientific validity of endpoints and patient selection strategies
• reduce uncertainty regarding the acceptability of innovative methodologies during later interactions with regulators

Overall, CHMP qualification opinions and advice help investigators develop protocols that are scientifically robust, methodologically sound, and better aligned with regulatory expectations, particularly when incorporating innovative tools into clinical research.