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New Product Filings to date
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Variations and Agency Responses filed to date
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Shortest time (months) to SAHPRA approval for New Medicine

Latest Industry News

  • Vaccines – News and updates14 January 2022, 1:54 pm
    14 January 2022 SAHPRA is currently evaluating a number of applications for emergency use (Section 21) and/or registration of COVID-19 vaccines. The table below shows the current status of the applications under consideration: As soon as any decision has been taken on these applications, based... The post Vaccines – News and updates appeared ...
  • SAHPRA and USP Announce MOU to Advance Regulatory Oversight for Medical Products in South Africa14 January 2022, 8:33 am
    14 January 2022 Embargo: Immediate release Joint Media Statement The South African Health Products Regulatory Authority (SAHPRA) has signed a Memorandum of Understanding (MOU) with the U.S. Pharmacopeia (USP) to help expand the availability of health products, including medical devices, that are safe, efficacious, and... The post SAHPRA and USP Ann...
  • Leading the way to job creation19 January 2022, 3:43 pm
    At the end of 2021, the Quarterly Labour Force Statistics (QLFS) for quarter three were released painting a grim unemployment landscape. Two-thirds of South African youth aged 15-34 are not working (61.3%, expanded definition). This is a crisis that must be dealt with for the sustainability of not only our industry but the broader economy. SAM...
  • 2022: A glance at the quarter ahead14 January 2022, 3:29 pm
    We start 2022 with optimism as we set out our plans for the year ahead. We have several transformation initiatives underway (including the first CEO Forum on 10 February 2022 and CEO Challenge) and have planned activities around procurement training, health technology assessment models, industry data collection, skills development and stakeholder e...