02.12.2016

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

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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 criteria (version 2). All files can be downloaded from the MCC website (see link(s) at the bottom of this article).

The new version of the Module 1 specification is to be implemented on May 01, 2017. The changes introduces are subtle and detailed in section 9 ("Update History") of the specification document.

The validation criteria have been changed substantially. The numbering has been adapted to the EU numbering scheme and a more detailed description for each criterion has been added.

[Source: MCC]

 

 

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