eCTD/eSubmissions

As of 1 August 2019 the South African Health Products Regulatory Authority (SAHPRA) only accepts electronic submissions for applications for registration of Biological and Pharmaceutical Health Products. The SAHPRA website contains all the forms and guidance documents related to the ZA eCTD specifications and content requirements.

Let us help you publish your eCTD – contact info@mra-regulatory.com.

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