New EMA Guidance Qualification of novel Methodologies for Drug Development
Recommendation
18-20 November 2025
Heidelberg, Germany
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing
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The European Medicines Agency EMA has published the revised Guidance to Applicants "Qualification of novel methodologies for drug development" (EMA/CHMP/SAWP/72894/2008). This guidance has already been finally agreed by CHMP in early 2009 and has now been revised for the second time. What's new is mainly the inclusion of the dates and deadlines for submission of letters of intent for qualification of novel methodologies.
The qualification process described in the document addresses innovative drug development methods and tools in pharmaceuticals R&D and compromises the whole procedure:
- Intention to submit a request
- Appointment of the Coordinator and the Qualification team on behalf of the CHMP (Committee for Medicinal Products for Human Use)
- Preparatory meeting
- Evaluation of data and discussion with the applicants
- SAWP (Scientific Advice Working Party) review
- CHMP adoption of Qualification Advice and discussion of Qualification Opinion
- Public consultation (for Qualification Opinion only)
- Adoption of the final CHMP Qualification Opinion
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