CRED 8 Presentations
01/07/2024
Centralised procedure (1)
• Products listed in Annex Regulation 726/2004 as mandatory for centralised procedure: • Biotech, advanced therapies, biosimilars • NCEs for HIV, cancer, neurodegenerative disorders, diabetes, autoimmune and viral diseases • Orphan drugs
(Additional information provided in the pre-read information)
The Organisation for Professionals in Regulatory Affairs
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Centralised procedure (2)
• Optional scope • NCEs, generics/hybrids or duplicates of centralised products • Significant therapeutic, scientific or technical innovation or the interests of patients • Some paediatric use MAAs
(Additional information provided in the pre-read information)
The Organisation for Professionals in Regulatory Affairs
10
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