CRED 8 Presentations

01/07/2024

1.5.1 Information on bibliographical applications (CP, MRP and DCP)

• Please refer to the guidance within the NtA, Volume 2A, Chpt. 1. • Well-established medicinal use (WEU) will be interpreted strictly. • Often disputed by Member States leading to ECJ (European Court of Justice) cases - worth reviewing case reviews. • ECJ – Expensive and time consuming. • Non-clinical and clinical overviews should be critical of literature search strategy, quality of data sources, e.g. GLP / GCP status. • Justify evidence of WEU ‘in the claimed therapeutic indication.’ (2001/83/EC article 10a). If the dossier includes both published and own data, the submission would be made under Directive 2001/83/EC article 8.3 and be considered a mixed MAA application.

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Module 1.5.2 information for generic, hybrid or biosimilar applications

• Biosimilar Applications (Article 10(4) of Directive 2001/83) • Include details on the similar biological medicinal product, its active substance, raw materials and manufacturing process. • Any differences compared to the reference product should be noted. • Describe the comparability exercise conducted vs the reference product with regard to quality, safety and efficacy. • Define the reference product used for the quality, safety and efficacy development

programme (table to be completed). • Biosimilars are exempt from PIPs

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