CRED 8 Presentations

03/07/2024

Agenda

• Fundamentals • Abridged applications

• Well established Use • Fixed Combination • Informed Consent • Generic • Line Extension/Hybrid • Biosimilars

• Data Protection • Strategic Considerations • Borderline Products • Combination Products • Herbals

The Organisation for Professionals in Regulatory Affairs

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Fundamentals…

• No medicinal product may be placed on the markets unless a marketing authorisation has been issued by a competent authority. • NCE - A chemical active substance that is not previously authorised in a medicinal product for human use in the European Union • From a chemical structure point of view not related to any other authorised substances • Considered to be new in itself as the structure of the therapeutic moiety is different from any other authorised so far as a medicinal product for human use. • If the chemical active substance is structurally related (salt, ester, ether, isomer, mixture of isomers, complex or derivative) of an already approved active substance, assess whether it shares the same therapeutic moiety at the site of the biological activity as the already approved active substance AND whether it differs significantly in properties with regard to safety and/or efficacy.

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-reflection-paper-chemical-structure-properties-criteria-be-considered-evaluation-new active_en.pdf

The Organisation for Professionals in Regulatory Affairs

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