Industry Workshop: Specification 3.1 Processes

Virtual

The South African Health Products Regulatory Authority (SAHPRA) hosted the third industry workshop in a series of informative sessions around eCTD. This webinar focused on Specification 3.1 processes. The processes covered included: Baselines-Iterative TOA Splitting the eCTD Multiple applications (replicas, clones, and duplicates) Line Extensions...

SAHPRA’s Regulatory Technical Forum (RTF) Virtual Meeting

Virtual

The South African Health Products Regulatory Authority (SAHPRA) hosted industry stakeholders at the Regulatory Technical Forum (RTF) Meeting. Areas discussed on the agenda included: EOI on model dossiers for training BAU applications and variations Medicines (Allopathic) Veterinary Medicines Complementary Medicines Inspectorate and Regulatory Compliance Medical...