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In pharmaceutical development, the preparation of CTD Tabulated Summaries is a critical component of regulatory submissions. These documents require scientific rigor, consistency, and accuracy, while also involving extensive data compilation, formatting, and verification activities.

The adoption of Directive (EU) 2024/3019 on urban wastewater treatment (UWWTD), published on 12 December 2024, introduces unprecedented requirements for the pharmaceutical industry. Integrated into the EU “Zero Pollution” Action Plan, this legislation imposes stringent management obligations for pharmaceutical residues

Since the sartans crisis in 2018, the detection of nitrosamines has highlighted systemic gaps in identifying contamination pathways across pharmaceutical supply chains. As impurities belonging to the “cohort of concern” following ICH M7 (R2), nitrosamines present exceptionally high carcinogenic potency.

L'apparition inattendue d'impuretés de N-nitrosamines dans les médicaments a marqué un tournant réglementaire majeur. Ces composés, connus dans l'environnement et l'alimentation, ont forcé l'industrie pharmaceutique mondiale à revoir ses processus. Face à cette situation, une coordination internationale sans précédent a vu le jour entre les agences réglementaires mondiales, telles que la FDA (États-Unis),