Regulatory authorities around the world continue to adopt internationally recognised data standards set by the ICH in an effort to improve the efficiency. The adoption of these standards not only allows individual national authorities to improve their own processes, but also allows for increased cooperation and information sharing among global regulatory authorities.
This whitepaper looks at the latest developments in eCTD implementation around the globe, including regulatory challenges in Brazil, China, the GCC and Russia, and comparison between eSubmissions in the US and EU.
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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.
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