02.12.2016
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 The MCC (Medicines Control Council) of South Afrika has released updated versions of their Module 1 eCTD specification (version 2.1) and corresponding South African validation...[mehr]
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06.05.2016
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 The Medicines Control Council (MCC) of South Africa has released an updated version of the "Questions & Answers Implementation of eCTD in South Africa". The new...[mehr]
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14.04.2015
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 The Australian Therapeutic Goods Administration (TGA) has released the first final specification for the Australian eCTD.
Since late 2014 the TGA was accepting eCTD submissions...[mehr]
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27.10.2014
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 The Medicines Control Council (MCC) of South Africa has updated their roadmap for the implementation of the eCTD. Since June last year an eCTD pilot phase is running at the MCC...[mehr]
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24.10.2014
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 The Australian Therapeutics Good Administration has updated their "Australian eCTD submissions: Frequently asked questions" website (see also link at the bottom of this...[mehr]
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05.09.2014
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 The Australian Therapeutic Goods Administration (TGA) has released more information to their eCTD Module 1 specification:
The eCTD technical files required to publish eCTDs...[mehr]
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29.08.2014
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 The Thai Drug Control Division (TDCD) a Division of the Thai Food and Drug Administration has released information about the Thai eSubmission project on the website of the...[mehr]
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