Qualification of novel methodologies for medicine development: High-level information on CHMP qualification advice

The European Medicines Agency (EMA) publishes high-level information on the Committee for Medicinal Products for Human Use (CHMP)'s qualification advice to promote transparency, collaboration and data sharing among methodology developers.
HumanResearch and development

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EMA publishes high-level information on requests for CHMP qualification advice, while preserving the confidentiality of the detailed advice.

This aims to:

  • Raise awareness of in-development novel methodologies
  • Encourage collaboration among methodology developers working on similar methodologies

CHMP provides advice on qualification plans for novel methodologies, including:

  • Scientific rationale
  • Proposed context(s) of use
  • Preliminary data supporting validity
  • Planned evidence generation to support a qualification opinion

For more information, see:

High-level information on CHMP qualification advice

Select the expandable panels below to find information on methodologies that received CHMP qualification advice, including:

  • Targeted context of use
  • Type of methodology
  • Applicant
  • Contact for public contact

The table below provides at-a-glance information on the [add title/topic of the methodology]:

Targeted context of use Digitally derived nocturnal scratch clinical outcome assessment to serve as secondary efficacy endpoint in clinical studies in atopic dermatitis.
Type of methodology Digitally derived clinical outcome assessment
Applicant Janssen Cilag / Johnson & Johnson
Contact for public enquiries contact@Janssen-emea.com

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13 October 2026

Page first published.

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