- UHRA Home
- Browsing by Author
Browsing by Author "Walker, Stuart"
Now showing items 1-14 of 14
-
Assessment of the effectiveness and efficiency of the economic community of West African States Medicines Regulatory Harmonization initiative by the pharmaceutical industry
Owusu-Asante, Mercy; Darko, Delese Mimi; Walker, Stuart; Salek, Sam (2023-05-09)Background: Following the establishment of Economic Community of West African States Medicines Regulatory Harmonization (ECOWAS-MRH) initiative in 2017, it was considered timely to carry out an evaluation of the current ... -
Assessment of the effectiveness and efficiency of the West Africa medicines regulatory harmonization initiative by the member countries
Owusu-Asante, Mercy; Darko, Delese Mimi; Walker, Stuart; Salek, Sam (2022-11-25)Background: The West Africa Health Organization launched the West Africa Medicines Regulatory Harmonization Project (WA-MRH) in 2017 with the overarching objective to improve the availability of high-quality, safe and ... -
Comparison of the registration process of the Medicines Control Authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: Benchmarking best practices
Sithole, Tariro; Salek, Sam; Mahlangu, Gugu; Walker, Stuart (2021-10-20)Background: Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving ... -
The Development and Validation of a Generic Instrument, QoDoS, for Assessing the Quality of Decision Making.
Donelan, R; Walker, Stuart; Salek, Mir-Saeed Shayegan (2016-07-13)Introduction: The impact of decision-making during the development and the regulatory review of medicines greatly influences the delivery of new medicinal products. Currently, there is no generic instrument that can be ... -
Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward
Ngum, Nancy; Mashingia, Jane; Ndomondo-Sigonda, Margareth; Walker, Stuart; Salek, Sam (2022-07-05)Background: For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical ... -
Evaluation of the effectiveness and efficiency of the East African community joint assessment procedure by pharmaceutical companies: Opportunities for improvement
Ngum, Nancy; Mashingia, Jane; Ndomondo-Sigonda, Margareth; Walker, Stuart; Salek, Sam (2022-11-03)Background: A 2021 study to determine the viewpoints among the seven member countries regarding the effectiveness (i.e., achieving the intended outcomes) and efficiency (i.e., achieving the intended outcomes in timely ... -
Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities
Owusu-Asante, Mercy; Darko, Delese Mimi; Asamoah-Okyere, Kwame Dei; Asante-Boateng, Samuel; Kermad, Adem; Walker, Stuart; Salek, Sam (2023-03-31)Purpose: This study aimed to assess the current regulatory review process of the food and drugs authority (FDA) Ghana by identifying key milestones, target timelines, good review practices and quality decision-making ... -
Evaluation of the Good Review Practices 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; Padayachee, Silverani; Sehloho, Tohlang; Khea, Akida; Fimbo, Adam; Munkombwe, Zuma; Mwale, Bernice; Salek, Sam; Walker, Stuart (2021-08-27)Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the ... -
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 ... -
Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward
Sithole, Tariro; Mahlangu, Gugu; Walker, Stuart; Salek, Sam (2022-04-25)Introduction: The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate ... -
Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward
Sithole, Tariro; Mahlangu, Gugu; Walker, Stuart; Salek, Sam (2022-04-25)Introduction: ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall ... -
Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening
Mashingia, Jane; Ngum, Nancy; Ndomondo-Sigonda, Margareth; Kermad, Adem; Bujar, Magda; Salek, Sam; Walker, Stuart (2023-05-31)Background: Seven national medicines regulatory authorities in the East African Community (EAC) have embraced regulatory reliance, harmonization and work sharing through the EAC Medicines Regulatory Harmonization programme. ... -
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 ...