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The South African Health Products Regulatory Authority (SAHPRA) hosted an informative workshop on the upcoming eCTD Specification 3.1 and the launch of the new Application Submission Portal. This was the first of three workshops. Presentations Download Presentation Watch Recording ...

19 November 2020 The Backlog Clearance Team has been made aware of a miscommunication in our Newsletter dated August 2020 and we would like to clarify the matter. It relates to the submission of Type I & II variation applications and states that Type I variations...