CRED 8 Presentations

03/07/2024

Line Extension – Change to active

• Changes to the active substance(s): • Replacement of the active substance(s) by a different salt/ester complex/derivative • Replacement by a different isomer, a different mixture of isomers, an isolated isomer • Replacement of a biological substance or product of biotechnology with one of a slightly different molecular structure • A new ligand or coupling mechanism for a radiopharmaceutical • Change to the extraction solvent or the ratio of herbal drug to herbal drug preparation

The Organisation for Professionals in Regulatory Affairs

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Line Extension – Change to product presentation

• Changes to strength, pharmaceutical form and route of administration: • Change of bioavailability

• Change of pharmacokinetics e.g. change in rate of release

• Change or addition of a new strength/potency • Change or addition of a new pharmaceutical form • Change or addition of a new route of administration

• The National Competent Authority may issue a new independent Marketing Authorisation (more common) • Or it may deal with it as a variation to the existing Marketing Authorisation • Line extensions can only be granted to the same MA holder as for the existing Marketing Authorisation • Modules 1 & 2 Updated • Modules 3, 4 & 5 include data relating to change – appropriate quality, non-clinical (toxicological) tests and clinical trials – maybe bioequivalence studies • Similar to Abridged Hybrid applications but for the holder of the existing authorised MA

The Organisation for Professionals in Regulatory Affairs

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