Registration & Life-cycle News

eCTD / eSubmissions have been mandated as the only means of submitting new applications for registration for pharmaceutical and biological Health Products, starting 1 August 2019.Significant changes have been implemented for the ZA regional content for eCTD/eSubmissions. The introduction of several new template documents and guidelines requires considerably more regulatory work to go into the creation of registration applications than before.ZA is aligning itself with the EU variation guidelines in terms of classifications and processes. An addendum to the Amendment Guideline has been issued 10 May 2019.SAHPRA has been developing portals for electronic submissions. These include a portal for submission of variations as well as one to manage the licensing for companies involved with complementary medicines. These are in various stages of development and testing and 2020 will see these becoming operational.

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We provide project-based mentoring for regulatory departments and bespoke training for your regulatory affairs team. New CPD requirements have been published by the

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