Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format ...
The US Food and Drug Administration (FDA) has announced the release of "major updates" to Module 1 of the electronic common technical documents (eCTD), used to supplement all eCTD submissions in the ...
Health Canada has released a new guidance document pertaining to the creation of the Canadian Module 1 backbone of the electronic Common Technical Document (eCTD), a standardized pharmaceutical review ...
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