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Browsing by Author "Danks, Lorraine"
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Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities
Danks, Lorraine; Semete-Makokotlela, Boitumelo; Otwombe, Kennedy; Parag, Yashmika; Walker, Stuart; Salek, Sam (2023-10-23)Introduction: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients’ access to medicines. This study considered whether reliance ... -
Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward
Sithole, Tariro; Mahlangu, Gugu; Capote, Velma; Sitoie, Tania; Shifotoka, Saren; Gaeseb, Johannes; Danks, Lorraine; Nkambule, Portia; Juma, Alex; Fimbo, Adam; Munkombwe, Zuma; Mwale, Bernice; Salek, Sam; Walker, Stuart (2021-08-27)Introduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and ... -
South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access
Keyter, Andrea; Salek, Sam; Danks, Lorraine; Nkambule, Portia; Semete-Makokotlela, Boitumelo; Walker, Stuart (2021-07-23)Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the ...