South Africa: MCC releases updated Module 1 eCTD specification and validation criteria

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]

South African MCC releases updated eCTD Q&A

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]

Australian TGA releases final eCTD specification, revises NeeS format

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]

South Africa MCC updates eCTD implementation roadmap

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]

Australian TGA updates eCTD FAQ

The Australian Therapeutics Good Administration has updated their "Australian eCTD submissions: Frequently asked questions" website (see also link at the bottom of this...[mehr]

Australian TGA releases technical eCTD files and further info to eCTD pilot

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]

Thai FDA releases draft eCTD specification and validation criteria

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]