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Global: ICH publishes updated eCTD Q&A´s

15.06.2009

In the updated version 1.17 of the ICH eCTD Questions & Answer document, a new question #64 has been added dealing with the presence of references to external websites in the...[more]

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Global: M1 specifications for CA, EU, JP and US available from ESTRI website

15.01.2009

 

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Global: ICH publishes eCTD specification 3.2.2

16.07.2008

ICH M2 EWG has defined, in the current document, the specification for the Electronic Common Technical Document (eCTD). The eCTD is defined as an interface for industry to agency...[more]

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