eCTD has been mandated as the only means of submitting new applications for registration for pharmaceutical and biological Health Products. Significant changes have been implemented for the administrative particulars for the ZA eCTD. 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 has aligned itself with the EU variation guidelines in terms of classifications and processes. Various guidelines related to Variations have been implemented. SAHPRA has developed portals for electronic submissions. These include portals and online submission processes for new applications, variations as well as one for managing the licensing of companies involved with complementary medicines.
The process of Renewals of Registrations has commenced and SAHPRA has issued several guidance documents related there. There is a submission plan that details the expectations for products registered in certain years to apply for renewals of those registrations. All newly registered products are now issued an expiry date for their registration and renewal applications are required to be submitted 6 months prior to that expiry date.
Guidance for the applications for registration of Medical Devices and In Vitro Diagnostics (IVDs) have been issued. This signals that SAHPRA is likely to call up these products for registration in the short to medium term. Most likely the expected changes to the Regulations governing Medical Devices and IVDs will herald in the start to the registration process.