Global CMC NDA

Efforts are currently under way within ICH to develop a common technical document (CTD) that will harmonize the CMC regulatory requirements for global development and marketing. Although some progress has been made 

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The CMC section for a NDA consists of a complete set of modules (2.3 and 3) where each individual module is global in its contents. Some additional country-specific documents (e.g., Environmental Assessment and Method Validation package for United States and QOS for EU and United States) still need to be prepared but many of the other technical reports may be suitable for both dossiers by simply reordering. The final EU Marketing Application (MA) or US NDA will consist of a specific arrangement of the modules with the appropriate (country-specific) headings. This modular approach reduces the redundancy and effort in preparing the documents. 

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