SAHPRA requests industry comments on the on the draft Variations Addendum for Orthodox Medicines, eCTD and eSubmission Guidelines, and New Registration Validation Template.

11 May 2019

One of the critical priorities of the South African Health Products Regulatory Authority (SAHPRA) is to clear its inherited backlog of new medicine registration and variation applications. SAHPRA’s Board has committed to achieving this objective within 2 years. In addition, SAHPRA also needs to ensure that such a crisis does not arise again. It is thus imperative that SAHPRA designs and implements new evaluation policies and models for evaluation.SAHPRA requests industry comments on  the draft Variations Addendum for Orthodox Medicines, eCTD and eSubmission Guidelines, and New Registration Validation Template.

Letter from the Acting CEO

Draft eCTD Guidelines v3 - Public Comments
Draft eSubmission Guidelines v1 (New) - Public Comments
New Registration Validation Template (eCTD) v3 - Public Comments
New Registration Validation Template (eSubmission) v3 - Public Comments
Variations Addendum for Orthodox Medicines  v1 (New) - Public Comments
[BACK TO News]