Medicine Registration & Life-cycle | ZA eCTD 3.1

News

The SAHPRA Portal for eCTD submissions using the ZA Specification 3.1 is going live on the 1^st of April 2025.

We can assist you with publishing your eCTDs using the latest specification to ensure that you won’t have to rework your application again.

Depending on your need – we can write the content requirements and publish the eCTD; or we can work with your regulatory department providing the content and we publish the eCTD.

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Medicine Registration & Life-cycle | Renewals

The renewal for product registrations is well under way and fees for renewal applications have now been published. Ensure that the renewal

Changes to Legislation: Medicines and Related Substances Act

New Fees have been published on the 12th of February 2025 (GG.52016). These have become effective for payments made to SAHPRA and a