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When a pharmaceutical company decides to get marketing authorisation in several world regions, it needs to carefully plan the dossier content to suffice data requirements for chemistry, manufacturing and controls (CMC), non-clinical and clinical modules across regions. In this process of reaching out to different world regions, the pharmaceutical development, manufacturing and distribution process has become highly complex - there is no ‘one size fits all’ as it depends on a large number of factors to be considered.
This whitepaper identifies the factors affecting submitting marketing authorisation applications around the world, common administrative requirements and the most important regulatory challenges in each region.
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This piece represents the views of the author and not necessarily the views of Informa Connect Life Sciences or the Global Pharmaceutical Regulatory Affairs Summit.