In the October released guidance, Medicines Control Council (MCC) has given clarity for manufacturers who are willing to submit applications for medicine registrations in electronic common technical document (eCTD) format.  The guidance mainly emphasized the implementation timelines of South African Module 1 eCTD Specification and Validation Criteria v2.0.

Having given clarity on the implementation timelines, medicine manufacturers aiming at submitting registration applications in eCTD format to MCC must keep in view that:

  • Starting 1 November 2016 the recent version of South African Module 1 specification for eCTD V2.0 is being implemented. Thus they must comply with the new standards while submitting medicine registration applications. However, MCC has given a grace period of 6 months, from 1 November 2016 to 30 April 2017, for both the versions of South African Module 1 specifications for eCTD.
  • If by chance the eCTD submissions made after 1 May 2017 do not comply with the South African Module 1 specification for eCTD V2.0, the applications will be rejected. That confirms the final deadline for eCTD submissions in newer format is 1 May 2017. The sequences of eCTD submissions made before the deadline need to be upgraded aligning with newer format and manufacturers have no need to update the previously submitted / older sequences and resubmit them.

In addition, MCC has also published V2.0 validation criteria that are said to be aligned with the EU validation criteria V6.1. For granular details have a look at MCC website where the agency said to be published a track change of all the modifications.

Aligning to the new specifications of eCTD formats not only requires a specialized knowledge on the particular region’s eCTD updates but also demands expertise in accurate implementation. With a proven expertise, a Regulatory submissions and publishing partner may suffice your requirement of being complied.


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