Module 6

04 October 2024

Applicant NAS Claim

Definitions

• Not previously authorised in the EU or • isomer, mixture of isomers, a complex or derivative or salt of a chemical substance authorised in EU with significant differences in Efficacy or Safety

CHEMICAL

New Active Substance

• Not previously authorised in the EU or • Significant differences in Efficacy or Safety due to due to differences in molecular structure, and/or nature of the source material and/or manufacturing process • radionuclide, or a ligand not previously authorised in the EU or • the coupling mechanism to link the molecule and the radionuclide has not been authorised previously in the EU

BIOLOGICAL

RADIO PHARMACEUTICAL

Annex I, Chapter 1 of Volume 2 A of the NTA

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

Classified as public by the European Medicines Agency

28

Essential considerations during the MAA evaluation

Presubmission Phase (PSP)

Evaluation Phase

MAA process

CHMP negative trend

Failure/Success of MAA

Examples

Benefit Balance of the product

Have you heard about it?..

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

29

Classified as public by the European Medicines Agency

29

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