Module 6

04 October 2024

Early support – Qualification of novel methodologies (1)

Q-Advice ‘letter of support’

Q-opinion ‘Final’

Q-opinion ‘Draft’

QoNM

Consultation with Scientific Community

SAWP recommendation CHMP endorsement

Established in 2008

Outcome based on the level of evidence during the procedure

20

An Agency perspective: the success and failure of a medicinal product in the EU

Classified as public by the European Medicines Agency

20

Early support – Qualification of novel methodologies (2)

2008-2020 Highlights on QoNM

All QoNM between January 2008- December 2020 (N=164)

Joint FDA procedure (N=18)

Biomarkers* (N=60)

Registry (N=11)

PRO or partly PRO ** (N=29)

Others e.g master protocols, simulation methods (N=20)

*Bakker et al, 2022, Clinical Pharmacology and Therapeutics. A review from 2008-2020 **Silva et al, 2022, British Pharmacological Society. A review 2013-2018

An Agency perspective: the success and failure of a medicinal product in the EU

21

Classified as public by the European Medicines Agency

21

11